Trial Outcomes & Findings for The (PIVOTAL) Study (NCT NCT00444821)

NCT ID: NCT00444821

Last Updated: 2021-10-11

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 728 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2021-10-11

Participant Flow

Participant milestones

Measure	Surveillance Subjects were assigned to serial ultrasound surveillance	Early Endovascular Repair AneuRx AAA stent graft / Talent AAA stent graft: Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
Overall Study STARTED	362	366
Overall Study Received AAA Repair	122	326
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	362	366

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The (PIVOTAL) Study

Baseline characteristics by cohort

Measure	Surveillance n=362 Participants Subjects were assigned to serial ultrasound surveillance	Early Endovascular Repair n=366 Participants AneuRx AAA stent graft / Talent AAA stent graft: Catheter based stent graft inserted to seal off an abdominal aortic aneurysm	Total n=728 Participants Total of all reporting groups
Age, Continuous	70.47 years STANDARD_DEVIATION 7.67 • n=5 Participants	70.46 years STANDARD_DEVIATION 7.80 • n=7 Participants	70.46 years STANDARD_DEVIATION 7.74 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	41 Participants n=7 Participants	97 Participants n=5 Participants
Sex: Female, Male Male	306 Participants n=5 Participants	325 Participants n=7 Participants	631 Participants n=5 Participants
Race/Ethnicity, Customized White race	343 Participants n=5 Participants	340 Participants n=7 Participants	683 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic ethnicity	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	362 Participants n=5 Participants	366 Participants n=7 Participants	728 Participants n=5 Participants
Baseline AAA size	4.45 cm STANDARD_DEVIATION 0.27 • n=5 Participants	4.45 cm STANDARD_DEVIATION 0.27 • n=7 Participants	4.45 cm STANDARD_DEVIATION 0.27 • n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Population: Study was terminated before all subjects enrolled and completed follow-up.

Outcome measures

Measure	Surveillance n=362 Participants Subjects were assigned to serial ultrasound surveillance	Early Endovascular Repair n=366 Participants AneuRx AAA stent graft / Talent AAA stent graft: Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
Number of Subjects That Experienced Rupture or Aneurysm Related Death	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Study was terminated before all subjects enrolled and completed follow-up.

After repair, AAA enlargement by >0.5cm

Outcome measures

Measure	Surveillance n=247 Participants Subjects were assigned to serial ultrasound surveillance	Early Endovascular Repair n=263 Participants AneuRx AAA stent graft / Talent AAA stent graft: Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
Aneurysm Growth >0.5 cm	35 Participants	15 Participants

SECONDARY outcome

Timeframe: study termination

Population: Study was terminated before all subjects enrolled and completed follow-up.

secondary interventions in those that had successful delivery and deployment by treatment group randomized to.

Outcome measures

Measure	Surveillance n=109 Participants Subjects were assigned to serial ultrasound surveillance	Early Endovascular Repair n=322 Participants AneuRx AAA stent graft / Talent AAA stent graft: Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
Secondary Endovascular Procedures Between the 30-day Post Treatment and 3-year Follow-up	5 Participants	12 Participants

Adverse Events

Surveillance

Serious events: 208 serious events

Other events: 21 other events

Deaths: 15 deaths

Early Endovascular Repair

Serious events: 166 serious events

Other events: 40 other events

Deaths: 15 deaths

Serious adverse events

Measure	Surveillance n=362 participants at risk Subjects were assigned to serial ultrasound surveillance	Early Endovascular Repair n=366 participants at risk AneuRx AAA stent graft / Talent AAA stent graft: Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
Blood and lymphatic system disorders Anemia	1.4% 5/362 • Number of events 5 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.82% 3/366 • Number of events 3 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Blood and lymphatic system disorders Thrombocytopenia	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Acute Coronary Syndrome	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Angina Pectoris	0.55% 2/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.82% 3/366 • Number of events 3 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Atrial Fibrillation	1.7% 6/362 • Number of events 6 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Atrial Fibrillation With Rapid Ventricular Response	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Atrial Flutter	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.55% 2/366 • Number of events 3 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Bradycardia	0.55% 2/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Cardiac Arrest	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.55% 2/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Cardio-Respiratory Arrest	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Cardiomyopathy	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Cardiopulmonary Arrest	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Chest Pain Cardiac	1.1% 4/362 • Number of events 4 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Congestive Cardiac Failure Aggravated	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Congestive Heart Failure	1.7% 6/362 • Number of events 7 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	1.6% 6/366 • Number of events 7 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Coronary Artery Disease	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	1.6% 6/366 • Number of events 6 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Coronary Artery Disease Aggravated	0.83% 3/362 • Number of events 3 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.55% 2/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Coronary Artery Disease Progression	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Coronary Artery Occlusion	0.55% 2/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Coronary Artery Stenosis	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Dilated Cardiomyopathy	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Heart Attack	0.55% 2/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Heart Block Third Degree	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Heart Failure	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Non St Segment Elevation Myocardial Infarction	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Non-Q Wave Mi	1.7% 6/362 • Number of events 6 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	1.6% 6/366 • Number of events 6 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Non-Sustained Ventricular Tachycardia	0.28% 1/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Palpitations	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Paroxysmal Atrial Fibrillation	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Paroxysmal Atrial Flutter	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Paroxysmal Atrial Tachycardia	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Paroxysmal Ventricular Tachycardia	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Q Wave Mi	0.83% 3/362 • Number of events 3 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.55% 2/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Sick Sinus Syndrome	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Sustained Ventricular Tachycardia	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Tachycardia	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Triple Vessel Disease	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Unstable Angina	1.1% 4/362 • Number of events 4 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Ventricular Tachycardia	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Cardiac disorders Wide Complex Tachycardia	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Ear and labyrinth disorders Benign Positional Vertigo	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Eye disorders Cataract (Left)	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Abdominal Distension	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Abdominal Pain	1.1% 4/362 • Number of events 4 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.55% 2/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Bleeding Duodenal Ulcer	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Bowel Ischemia	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.55% 2/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Chronic Abdominal Pain	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Colitis	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Colitis Ulcerative	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Colon Perforation	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Constipation	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Crohns Disease Aggravated	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Diaphragmatic Hernia	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Diarrhea	0.55% 2/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Diverticulitis	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Epigastric Discomfort	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Esophagitis Ulcerative	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Gastric Ulcer Perforated	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Gastroesophageal Reflux Disease	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Gastrointestinal Bleeding	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Gerd	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Gi Bleed	0.55% 2/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.55% 2/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Hematemesis	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Hemoperitoneum	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Ileus	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	1.4% 5/366 • Number of events 5 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Incarcerated Inguinal Hernia	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Inguinal Hernia	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Left Lower Quadrant Pain	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Lower Gastrointestinal Bleeding	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.55% 2/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Mallory Weiss Tear	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Nausea	0.55% 2/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.55% 2/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Nausea Aggravated	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Obstipation	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Rectal Bleeding	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Rectus Sheath Hematoma	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Ruptured Diverticulum	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Small Bowel Obstruction	0.28% 1/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.55% 2/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Ugi Bleed	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Umbilical Hernia	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Unspecified Disorder Of Intestine	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Gastrointestinal disorders Vomiting	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.55% 2/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
General disorders Acute Chest Pain	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
General disorders Acute Febrile Illness	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
General disorders Acute Pain	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
General disorders Central Line Complication	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
General disorders Chest Pain	2.2% 8/362 • Number of events 10 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	1.9% 7/366 • Number of events 10 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
General disorders Death	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
General disorders Drowning	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
General disorders Edema Legs	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
General disorders Endoleak	1.1% 4/362 • Number of events 5 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.82% 3/366 • Number of events 3 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
General disorders Fever	0.55% 2/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	1.4% 5/366 • Number of events 5 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
General disorders Fever Of Unknown Origin	0.83% 3/362 • Number of events 3 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.55% 2/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
General disorders General Malaise	0.55% 2/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
General disorders Multiple Organ Failure	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.82% 3/366 • Number of events 3 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
General disorders Nonspecific Chest Pain	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
General disorders Stent-Graft Endoleak Type Ii	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
General disorders Unspecified Chest Pain	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
General disorders Weakness	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Hepatobiliary disorders Acute Cholecystitis	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Hepatobiliary disorders Autoimmune Hepatitis	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Hepatobiliary disorders Cholecystitis	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Hepatobiliary disorders Cholecystolithiasis	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Hepatobiliary disorders Cholelithiasis	0.55% 2/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Hepatobiliary disorders Common Bile Duct Stone	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Hepatobiliary disorders Liver Cirrhosis	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Hepatobiliary disorders Liver Failure	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Immune system disorders Allergic Angioedema	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Immune system disorders Allergic Reaction	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Immune system disorders Anaphylactic Shock	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Immune system disorders Anaphylaxis	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Immune system disorders Systemic Inflammatory Response Syndrome	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Acute Appendicitis	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Appendicitis	0.83% 3/362 • Number of events 3 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Bronchitis	0.83% 3/362 • Number of events 3 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Bronchitis Bacterial	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Catheter Site Infection	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Cellulitis	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.55% 2/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Cellulitis Of Arm	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Cellulitis Of Face	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Cold	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Community Acquired Pneumonia	0.83% 3/362 • Number of events 4 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.55% 2/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Gastroenteritis	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Groin Abscess	0.55% 2/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Hospital Acquired Pneumonia	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Kidney Infection	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Lung Abscess	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Mrsa Wound Infection	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Orchitis	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Osteomyelitis	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Pneumonia	3.0% 11/362 • Number of events 13 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	2.7% 10/366 • Number of events 11 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Post Procedural Pneumonia	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Postoperative Infection	0.55% 2/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Pyelonephritis	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Sepsis	1.7% 6/362 • Number of events 7 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	1.4% 5/366 • Number of events 5 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Septic Shock	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Surgical Wound Infection	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Urinary Tract Infection	0.55% 2/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	1.1% 4/366 • Number of events 4 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Viral Encephalitis	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Viral Syndrome	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Infections and infestations Wound Infection	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.82% 3/366 • Number of events 3 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Anemia Postoperative	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Ankle Fracture	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Automobile Accident	0.28% 1/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Back Strain	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Broken Leg	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Clavicle Fracture	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Closed Head Injury	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Fall	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.55% 2/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Femur Fracture	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Fractured Sternum	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Hip Fracture	0.28% 1/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Implantation Complication	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Incision Site Complication	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Injury To Pulmonary Blood Vessel	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Intraoperative Bleeding	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Laceration Of Blood Vessel	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Liver Laceration	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Lumbar Spine Compression Fracture	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Motor Vehicle Accident	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.55% 2/366 • Number of events 3 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Multiple Fractures	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Postoperative Hypotension	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Postoperative Nausea	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Rib Fracture	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Seroma	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Spinal Compression Fracture	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Spinal Fracture	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Splenic Laceration	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Vascular Graft Thrombosis	1.9% 7/362 • Number of events 8 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	1.1% 4/366 • Number of events 4 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Injury, poisoning and procedural complications Wound Oozing	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Investigations Creatinine Increased	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.82% 3/366 • Number of events 3 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Investigations Cystoscopy	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Investigations Lung Function Decreased	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Metabolism and nutrition disorders Dehydration	0.55% 2/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	1.6% 6/366 • Number of events 6 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Musculoskeletal and connective tissue disorders Back Pain	0.83% 3/362 • Number of events 3 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Musculoskeletal and connective tissue disorders Cervical Spinal Stenosis	0.28% 1/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Musculoskeletal and connective tissue disorders Degenerative Joint Disease	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Musculoskeletal and connective tissue disorders Gonarthrosis	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Musculoskeletal and connective tissue disorders Gouty Arthritis	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Musculoskeletal and connective tissue disorders Hip Arthrosis	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Musculoskeletal and connective tissue disorders Hips Osteoarthritis	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Musculoskeletal and connective tissue disorders Intervertebral Disc Bulging	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Musculoskeletal and connective tissue disorders Jaw Pain	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Musculoskeletal and connective tissue disorders Knee Osteoarthritis	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Musculoskeletal and connective tissue disorders Low Back Pain	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Musculoskeletal and connective tissue disorders Lower Extremities Weakness Of	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Musculoskeletal and connective tissue disorders Lumbar Spinal Stenosis	0.55% 2/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Musculoskeletal and connective tissue disorders Spinal Stenosis Cervical	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Respiratory, thoracic and mediastinal disorders Nosebleed	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma Gastric	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma Of Prostate	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain Tumor	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	0.55% 2/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoma Lung	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic Lymphocytic Leukemia	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Cancer	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal Papillary-Mucinous Carcinoma Of Pancreas	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liver Adenocarcinoma	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Cancer	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.82% 3/366 • Number of events 3 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Cancer Metastatic	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Cancer Recurrent	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Carcinoma	0.55% 2/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanoma Skin	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Merkel Cell Carcinoma	0.28% 1/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Carcinoma	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Carcinoma Of The Bladder	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Small Cell Lung Cancer	0.28% 1/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Small Cell Lung Cancer Metastatic	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Fibroma	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Cancer	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cancer	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small Cell Carcinoma Of The Lung	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small Cell Lung Cancer Metastatic	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma Of Lung	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Nervous system disorders Basal Ganglia Haemorrhage	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Nervous system disorders Cardiac Syncope	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.82% 3/366 • Number of events 3 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Nervous system disorders Carotid Artery Stenosis	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	1.1% 4/366 • Number of events 4 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Nervous system disorders Cerebral Bleeding	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Nervous system disorders Cerebral Edema	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Nervous system disorders Cva	1.9% 7/362 • Number of events 7 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	1.1% 4/366 • Number of events 5 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Nervous system disorders Dizziness	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Nervous system disorders Embolic Stroke	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Nervous system disorders Headache Recurrent	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Nervous system disorders Intracerebral Hemorrhage	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Nervous system disorders Metabolic Encephalopathy	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Nervous system disorders Migraine Headache	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Nervous system disorders Near Syncope	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.55% 2/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Nervous system disorders Paralysis	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Nervous system disorders Paresthesia Lower Limb	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Nervous system disorders Parkinson's Disease	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Nervous system disorders Pontine Haemorrhage	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Nervous system disorders Sciatica	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Nervous system disorders Stroke	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Nervous system disorders Subarachnoid Hemorrhage	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Nervous system disorders Syncope	0.55% 2/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	1.1% 4/366 • Number of events 4 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Nervous system disorders Tia	1.1% 4/362 • Number of events 4 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.55% 2/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Nervous system disorders Vagal Reaction	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Product Issues Stent-Graft Migration	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Psychiatric disorders Anxiety Depression	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Psychiatric disorders Anxiety Due To General Medical Condition	1.4% 5/362 • Number of events 5 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Psychiatric disorders Mental Status Changes	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Psychiatric disorders Post-Traumatic Stress Disorder	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Psychiatric disorders Stress	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Psychiatric disorders Substance-Induced Mood Disorder	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Psychiatric disorders Suicide Attempt	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Renal and urinary disorders Acute Renal Failure	0.55% 2/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.55% 2/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Renal and urinary disorders End Stage Renal Disease (Esrd)	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Renal and urinary disorders Hydronephrosis	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Renal and urinary disorders Kidney Stone	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Renal and urinary disorders Renal Artery Occlusion	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Renal and urinary disorders Renal Disorder Nos	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Renal and urinary disorders Renal Failure Aggravated	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Renal and urinary disorders Renal Infarct	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Renal and urinary disorders Renal Insufficiency	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Renal and urinary disorders Ureteral Calculus	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Renal and urinary disorders Urinary Retention	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Renal and urinary disorders Voiding Difficulty	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Reproductive system and breast disorders Benign Prostatic Hypertrophy	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Reproductive system and breast disorders Enlarged Prostate	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Reproductive system and breast disorders Prostatitis	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Reproductive system and breast disorders Scrotal Swelling	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Airways Disease Exacerbated	0.55% 2/362 • Number of events 3 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Respiratory, thoracic and mediastinal disorders Copd Exacerbation	1.9% 7/362 • Number of events 9 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	2.2% 8/366 • Number of events 12 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Respiratory, thoracic and mediastinal disorders Hemoptysis	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Respiratory, thoracic and mediastinal disorders Lung Nodule	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.55% 2/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	1.7% 6/362 • Number of events 6 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Respiratory, thoracic and mediastinal disorders Respiratory Disorder Nos	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.82% 3/366 • Number of events 3 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Respiratory, thoracic and mediastinal disorders Respiratory Insufficiency	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Respiratory, thoracic and mediastinal disorders Shortness Of Breath	1.1% 4/362 • Number of events 5 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	1.4% 5/366 • Number of events 7 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Respiratory, thoracic and mediastinal disorders Subacute Pulmonary Edema	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Skin and subcutaneous tissue disorders Decubitus Ulcer	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Anal Skin Tag Excision	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Aortic Aneurysm Repair	1.4% 5/362 • Number of events 5 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Back Surgery	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Cardiac Catheterization	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.55% 2/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Carotid Endarterectomy	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.55% 2/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Cholecystectomy	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Colostomy Closure	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Coronary Arterial Stent Insertion	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Coronary Artery Bypass	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Craniotomy	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Hemodialysis	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	1.1% 4/366 • Number of events 5 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Hernia Repair	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Hip Replacement	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Hospitalisation	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Implantable Defibrillator Insertion	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Intubation	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.55% 2/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Knee Surgery	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Lung Lobectomy	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.55% 2/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Open Reduction Of Fracture	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Open Reduction Of Fracture With Internal Fixation	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Pseudophakia	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Rehabilitation Therapy	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Revision Of Total Knee Arthroplasty	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Surgical Intervention	1.7% 6/362 • Number of events 6 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	1.1% 4/366 • Number of events 4 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Total Gastrectomy	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Total Knee Replacement	1.1% 4/362 • Number of events 4 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	1.4% 5/366 • Number of events 5 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Triple Vessel Bypass Graft	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Surgical and medical procedures Vascular Stent Insertion	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Abdominal Aortic Aneurysm	9.4% 34/362 • Number of events 34 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Abdominal Aortic Aneurysm Enlargement	23.8% 86/362 • Number of events 86 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Acute Hypotension	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Aneursym	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Aneurysm	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Aneurysm Enlargement	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Aneurysm Ruptured	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Arterial Occlusion	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Ascending Aortic Dissection	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Carotid Artery Stenosis	1.1% 4/362 • Number of events 4 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Claudication	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.55% 2/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Dvt	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.55% 2/366 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Femoral Artery Thrombosis	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Groin Hematoma	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Hypertension	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Hypotension	0.55% 2/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.82% 3/366 • Number of events 3 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Iliac Artery Rupture	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Iliac Artery Stenosis	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Leg Ischemia	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Low Blood Pressure	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Peipheral Artery Aneurysm	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Peripheral Vascular Disease	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Popliteal Artery Aneurysm	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Popliteal Artery Occlusion	0.00% 0/362 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.27% 1/366 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Thrombosis	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Vascular Disorder	0.55% 2/362 • Number of events 2 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	1.4% 5/366 • Number of events 5 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Vascular disorders Venous Stasis Ulcer	0.28% 1/362 • Number of events 1 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	0.00% 0/366 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.

Other adverse events

Measure	Surveillance n=362 participants at risk Subjects were assigned to serial ultrasound surveillance	Early Endovascular Repair n=366 participants at risk AneuRx AAA stent graft / Talent AAA stent graft: Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
General disorders Endoleak	5.8% 21/362 • Number of events 21 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.	10.9% 40/366 • Number of events 47 • SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group. Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.

Additional Information

Kristel Wittebols

Medtronic

Phone: 707-591-3275

Email: kristel.wittebols@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place