Trial Outcomes & Findings for Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used as a Bridging Stent With Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries (NCT NCT05143138)

NCT ID: NCT05143138

Last Updated: 2025-08-22

Results Overview

Uninterrupted patency with no occlusion or procedure performed to maintain patency on the VBX Stent Graft or native target vessel. Interventions intended to treat endoleak or stent disconnection do not count as loss of primary patency. Binomial proportions were calculated at 12 month follow-up.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Target enrollment: 259 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2025-08-22

Participant Flow

There were 259 patients enrolled and divided as follows: 136 subjects in the BEVAR cohort, 92 in the FEVAR cohort and 31 in the MIXED cohort Fourteen investigators at 14 sites participated in the registry within 6 European countries. All the 14 sites are still active and enrolled subjects.

Participant milestones

Measure	fEVAR Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a fenestrated stent graft to allow endovascular aneurysm repair GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent	bEVAR Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched stent graft to allow endovascular aneurysm repair GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent	fEVAR and bEVAR Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched and fenestrated stent graft to allow endovascular aneurysm repair GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent
Overall Study STARTED	92	136	31
Overall Study COMPLETED	84	96	30
Overall Study NOT COMPLETED	8	40	1

Reasons for withdrawal

Measure	fEVAR Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a fenestrated stent graft to allow endovascular aneurysm repair GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent	bEVAR Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched stent graft to allow endovascular aneurysm repair GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent	fEVAR and bEVAR Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched and fenestrated stent graft to allow endovascular aneurysm repair GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent
Overall Study Death	5	35	1
Overall Study Lost to Follow-up	2	4	0
Overall Study withdrawal	1	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	fEVAR n=92 Participants Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a fenestrated stent graft to allow endovascular aneurysm repair GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent	bEVAR n=136 Participants Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched stent graft to allow endovascular aneurysm repair GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent	fEVAR and bEVAR n=31 Participants Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched and fenestrated stent graft to allow endovascular aneurysm repair GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent	Total n=259 Participants Total of all reporting groups
Age, Continuous	74 Years n=92 Participants	74 Years n=136 Participants	72 Years n=31 Participants	74 Years n=259 Participants
Sex: Female, Male Female	12 Participants n=92 Participants	37 Participants n=136 Participants	14 Participants n=31 Participants	63 Participants n=259 Participants
Sex: Female, Male Male	80 Participants n=92 Participants	99 Participants n=136 Participants	17 Participants n=31 Participants	196 Participants n=259 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Netherlands	11 participants n=92 Participants	21 participants n=136 Participants	0 participants n=31 Participants	32 participants n=259 Participants
Region of Enrollment Sweden	13 participants n=92 Participants	18 participants n=136 Participants	7 participants n=31 Participants	38 participants n=259 Participants
Region of Enrollment Norway	22 participants n=92 Participants	1 participants n=136 Participants	7 participants n=31 Participants	30 participants n=259 Participants
Region of Enrollment Denmark	19 participants n=92 Participants	19 participants n=136 Participants	6 participants n=31 Participants	44 participants n=259 Participants
Region of Enrollment Italy	16 participants n=92 Participants	62 participants n=136 Participants	5 participants n=31 Participants	83 participants n=259 Participants
Region of Enrollment Spain	11 participants n=92 Participants	15 participants n=136 Participants	6 participants n=31 Participants	32 participants n=259 Participants
Serum Creatinine	1.1 mg/dL n=92 Participants	1.1 mg/dL n=136 Participants	0.9 mg/dL n=31 Participants	1.1 mg/dL n=259 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Study endpoints were planned and calculated for the two primary cohorts only. Subjects that are not discontinued prior to 1 year window and with imaging within 1 year window.

Uninterrupted patency with no occlusion or procedure performed to maintain patency on the VBX Stent Graft or native target vessel. Interventions intended to treat endoleak or stent disconnection do not count as loss of primary patency. Binomial proportions were calculated at 12 month follow-up.

Outcome measures

Measure	fEVAR n=79 Participants Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a fenestrated stent graft to allow endovascular aneurysm repair GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent	bEVAR n=90 Participants Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched stent graft to allow endovascular aneurysm repair GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent
Number of Participants With Target Vessel Patency	78 Participants	84 Participants

Adverse Events

fEVAR

Serious events: 44 serious events

Other events: 6 other events

Deaths: 5 deaths

bEVAR

Serious events: 89 serious events

Other events: 7 other events

Deaths: 35 deaths

fbEVAR

Serious events: 21 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Measure	fEVAR n=92 participants at risk Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a fenestrated stent graft to allow endovascular aneurysm repair GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent	bEVAR n=136 participants at risk Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched stent graft to allow endovascular aneurysm repair GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent	fbEVAR n=31 participants at risk Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a fenetrated or branched stent graft to allow endovascular aneurysm repair GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	1.5% 2/136 • Number of events 2 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Blood and lymphatic system disorders Anemia	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	2.2% 3/136 • Number of events 3 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Blood and lymphatic system disorders Splenic infarction	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Cardiac disorders Acute myocardial infarction	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Cardiac disorders Atrial fibrillation	2.2% 2/92 • Number of events 2 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	1.5% 2/136 • Number of events 2 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Cardiac disorders Atrial flutter	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Cardiac disorders Cardiac arrest	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	2.2% 3/136 • Number of events 3 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Cardiac disorders Cardiac tamponade	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Cardiac disorders Chest pain - cardiac	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Cardiac disorders Decompensated heart failure	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Cardiac disorders Heart failure	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	1.5% 2/136 • Number of events 2 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Cardiac disorders Ischemic heart disease	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Cardiac disorders NSTEMI	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Cardiac disorders Non-sustained ventricular tachycardia	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Cardiac disorders Paroxysmal atrial flutter	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Cardiac disorders Right heart failure	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Cardiac disorders STEMI	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Cardiac disorders Supraventricular tachycardia	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Gastrointestinal disorders Abdominal pain	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	1.5% 2/136 • Number of events 2 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Gastrointestinal disorders Bleeding duodenal ulcer	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Gastrointestinal disorders Bleeding gastric ulcer	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Gastrointestinal disorders Blood in stool	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Gastrointestinal disorders Bowel ischaemia	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Gastrointestinal disorders Bowel ischemia	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Gastrointestinal disorders Constipation	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Gastrointestinal disorders Hematochezia	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Gastrointestinal disorders Intestinal ischemia	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Gastrointestinal disorders Paralytic ileus	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Gastrointestinal disorders Retroperitoneal hematoma	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Gastrointestinal disorders Superior mesenteric artery dissection	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Gastrointestinal disorders Vomiting	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
General disorders Fatigue	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
General disorders Fever	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	1.5% 2/136 • Number of events 2 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
General disorders Fever of unknown origin	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
General disorders Hyposthenia	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
General disorders Hypothermia	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
General disorders In-stent arterial stenosis	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	3.2% 1/31 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
General disorders Multi organ failure	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
General disorders Multiorgan failure	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	1.5% 2/136 • Number of events 2 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
General disorders Non-cardiac chest pain	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	1.5% 2/136 • Number of events 2 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
General disorders Stent thrombosis	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 2 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
General disorders Stent-graft endoleak type IA	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	1.5% 2/136 • Number of events 2 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	3.2% 1/31 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
General disorders Stent-graft endoleak type IB	4.3% 4/92 • Number of events 4 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	1.5% 2/136 • Number of events 2 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
General disorders Stent-graft endoleak type IC	2.2% 2/92 • Number of events 2 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	5.9% 8/136 • Number of events 8 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	6.5% 2/31 • Number of events 3 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
General disorders Stent-graft endoleak type II	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	5.1% 7/136 • Number of events 10 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	9.7% 3/31 • Number of events 3 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
General disorders Stent-graft endoleak type III	5.4% 5/92 • Number of events 6 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	3.7% 5/136 • Number of events 5 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	9.7% 3/31 • Number of events 3 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
General disorders Unknown cause of death	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	2.9% 4/136 • Number of events 4 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
General disorders Vascular stent-graft occlusion	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Hepatobiliary disorders Acute cholecystitis	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Hepatobiliary disorders Choledocholithiasis	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Hepatobiliary disorders Cholelithiasis	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Immune system disorders Allergy to antibiotic	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Immune system disorders Anaphylactic reaction to contrast agent	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Infections and infestations Bacteremia	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Infections and infestations COVID-19	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Infections and infestations Leg infection	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Infections and infestations Meningitis	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Infections and infestations Nosocomial pneumonia	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Infections and infestations Pneumonia	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Infections and infestations Septic shock	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	1.5% 2/136 • Number of events 2 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Infections and infestations Urinary tract infection	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Infections and infestations Urosepsis	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	1.5% 2/136 • Number of events 2 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Infections and infestations Vascular graft infection	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Injury, poisoning and procedural complications Elbow fracture	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Injury, poisoning and procedural complications Femoral artery pseudoaneurysm	2.2% 2/92 • Number of events 2 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Injury, poisoning and procedural complications Fractured ethmoid	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Injury, poisoning and procedural complications Intraoperative arterial injury	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Injury, poisoning and procedural complications Postoperative renal failure	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Injury, poisoning and procedural complications Procedural headache	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Injury, poisoning and procedural complications Pseudoaneurysm	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Injury, poisoning and procedural complications Vascular access site bleeding	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	3.2% 1/31 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Injury, poisoning and procedural complications Vascular access site thrombosis	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Injury, poisoning and procedural complications Vascular graft stenosis	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	3.2% 1/31 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Injury, poisoning and procedural complications Vascular graft thrombosis	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Investigations C-reactive protein increased	2.2% 2/92 • Number of events 2 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Investigations Ejection fraction decreased	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Metabolism and nutrition disorders Fluid overload	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Metabolism and nutrition disorders Hypokalaemia	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Musculoskeletal and connective tissue disorders Compartment syndrome	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Musculoskeletal and connective tissue disorders Flank pain	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Musculoskeletal and connective tissue disorders Pain of lower extremities	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	3.2% 1/31 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Advanced lung cancer	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Nervous system disorders Cerebrospinal fistula	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Nervous system disorders Cerebrospinal fluid rhinorrhoea	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Nervous system disorders Cognitive impairment	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Nervous system disorders Hypoaesthesia	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Nervous system disorders Ischemic stroke	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Nervous system disorders Limb paresis	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Nervous system disorders Neurological impairment	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	3.2% 1/31 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Nervous system disorders Paraparesis	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Nervous system disorders Paraplegia	2.2% 2/92 • Number of events 2 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	2.2% 3/136 • Number of events 3 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	9.7% 3/31 • Number of events 3 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Nervous system disorders Polyneuropathy	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	3.2% 1/31 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Nervous system disorders Sensory loss	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Nervous system disorders Spinal cord ischemia	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	4.4% 6/136 • Number of events 6 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Nervous system disorders Spinal subdural hematoma	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	3.2% 1/31 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Nervous system disorders Stroke	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	2.9% 4/136 • Number of events 4 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Nervous system disorders Toxic metabolic encephalopathy	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Product Issues Device migration	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Product Issues Device occlusion	2.2% 2/92 • Number of events 2 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Product Issues Stent occlusion	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	2.2% 3/136 • Number of events 3 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Product Issues Thrombosis in device	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Psychiatric disorders Confusion	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Psychiatric disorders Confusion state	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Psychiatric disorders Delirium	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Renal and urinary disorders Acute kidney injury	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	2.9% 4/136 • Number of events 4 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Renal and urinary disorders Acute nonoliguric renal failure	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Renal and urinary disorders Acute on chronic renal failure	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Renal and urinary disorders Acute renal failure	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	1.5% 2/136 • Number of events 2 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Renal and urinary disorders Acute renal insufficiency	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Renal and urinary disorders Bladder paralysis	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Renal and urinary disorders Chronic kidney disease	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Renal and urinary disorders End stage renal disease	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Renal and urinary disorders Hematuria	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Renal and urinary disorders Hydronephrosis	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Renal and urinary disorders Impaired renal function	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 2 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Renal and urinary disorders Kidney failure	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Renal and urinary disorders Renal artery dissection	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Renal and urinary disorders Renal artery occlusion	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 2 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Renal and urinary disorders Renal artery perforation	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Renal and urinary disorders Renal artery stenosis	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Renal and urinary disorders Renal artery thrombosis	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Renal and urinary disorders Renal failure	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Renal and urinary disorders Renal function aggravated	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	3.2% 1/31 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Renal and urinary disorders Renal hematoma	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	3.2% 1/31 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Renal and urinary disorders Renal infarct	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	2.2% 3/136 • Number of events 3 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Renal and urinary disorders Renal infarction	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Renal and urinary disorders Retention urine	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Renal and urinary disorders Urinary retention	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Respiratory, thoracic and mediastinal disorders Acute respiratory insufficiency	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease exacerbation	3.3% 3/92 • Number of events 3 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Respiratory, thoracic and mediastinal disorders Dyspnea exacerbated	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	3.2% 1/31 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 2 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Respiratory, thoracic and mediastinal disorders Pulmonary edema	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Acute limb ischemia	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Aneurysm enlargement	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Aortic aneurysm rupture	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Aortic dilatation	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	3.2% 1/31 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Aortic intramural hematoma	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	3.2% 1/31 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Aortoiliac occlusive disease	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Arterial bleeding	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	3.2% 1/31 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Arterial rupture	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	3.2% 1/31 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Celiac artery occlusion	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders External iliac artery perforation	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Extremity necrosis	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Femoral artery aneurysm	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	3.2% 1/31 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Femoral artery occlusion	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	3.2% 1/31 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Femoral artery perforation	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Femoral artery thrombosis	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Hemorrhagic shock	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Hypovolemic shock	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Iliac artery dissection	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Iliac artery occlusion	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Iliac artery stenosis	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Iliac artery thrombosis	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Lymphocele	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Penetrating aortic ulcer	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Peripheral artery aneurysm rupture	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Thoracic aneurysm, ruptured	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.74% 1/136 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Thoracic aortic aneurysm	1.1% 1/92 • Number of events 1 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Type A aortic dissection	0.00% 0/92 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	1.5% 2/136 • Number of events 2 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment
Vascular disorders Type B aortic dissection	2.2% 2/92 • Number of events 2 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/136 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	0.00% 0/31 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment

Other adverse events

Measure	fEVAR n=92 participants at risk Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a fenestrated stent graft to allow endovascular aneurysm repair GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent	bEVAR n=136 participants at risk Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched stent graft to allow endovascular aneurysm repair GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent	fbEVAR n=31 participants at risk Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a fenetrated or branched stent graft to allow endovascular aneurysm repair GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent
General disorders Stent-graft endoleak type II	6.5% 6/92 • Number of events 6 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	5.1% 7/136 • Number of events 7 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment	9.7% 3/31 • Number of events 3 • 1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows. Serious Adverse Event: Any adverse event that led to any of the following: 1. death 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 3. fetal distress, fetal death, or a congenital abnormality, or birth defect including physical or mental impairment

Additional Information

Cinzia Santin, Clinical Study Mgt, Gore Medical Products

WL Gore

Phone: +393463645539

Email: csantin@wlgore.com

Results disclosure agreements

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