Trial Outcomes & Findings for GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03) (NCT NCT04706273)

NCT ID: NCT04706273

Last Updated: 2024-09-20

Results Overview

Primary assisted patency is defined as hemodynamic evidence of flow through a device that had not required a Target lesion revascularization to restore flow after total occlusion. Kaplan-Meier estimates created for each time point.

• Recruitment status: COMPLETED
• Target enrollment: 321 participants
• Primary outcome timeframe: 12 and 24 months
• Results posted on: 2024-09-20

Participant Flow

Unit of analysis: limbs

Participant milestones

Measure	GORE® VIABAHN® Endoprosthesis Participants with symptomatic peripheral arterial disease in superficial femoral artery lesions. GORE® VIABAHN® Endoprosthesis: Participants receiving the GORE® VIABAHN® Endoprosthesis
Overall Study STARTED	321 324
Overall Study COMPLETED	136 136
Overall Study NOT COMPLETED	185 188

Reasons for withdrawal

Measure	GORE® VIABAHN® Endoprosthesis Participants with symptomatic peripheral arterial disease in superficial femoral artery lesions. GORE® VIABAHN® Endoprosthesis: Participants receiving the GORE® VIABAHN® Endoprosthesis
Overall Study Withdrawal by Subject	27
Overall Study Physician Decision	1
Overall Study Lost to Follow-up	42
Overall Study Death	85
Overall Study Amputation that removes study device	2
Overall Study Surgical bypass	3
Overall Study Changing hospital	23
Overall Study Unable to attend hospital	2

Baseline Characteristics

3 participants are missing age

Baseline characteristics by cohort

Measure	GORE® VIABAHN® Endoprosthesis n=321 Participants Participants with symptomatic peripheral arterial disease in superficial femoral artery lesions. GORE® VIABAHN® Endoprosthesis: Participants receiving the GORE® VIABAHN® Endoprosthesis
Age, Continuous	73.9 years STANDARD_DEVIATION 8.7 • n=318 Participants • 3 participants are missing age
Sex: Female, Male Female	73 Participants n=321 Participants
Sex: Female, Male Male	248 Participants n=321 Participants
Region of Enrollment Japan	321 participants n=321 Participants

PRIMARY outcome

Timeframe: 12 and 24 months

Population: Participant limbs treated

Primary assisted patency is defined as hemodynamic evidence of flow through a device that had not required a Target lesion revascularization to restore flow after total occlusion. Kaplan-Meier estimates created for each time point.

Outcome measures

Measure	GORE® VIABAHN® Endoprosthesis n=324 limbs Participants with symptomatic peripheral arterial disease in superficial femoral artery lesions. GORE® VIABAHN® Endoprosthesis: Participants receiving the GORE® VIABAHN® Endoprosthesis
Primary Assisted Patency 12 months	0.920 probability Interval 0.88 to 0.946
Primary Assisted Patency 24 months	0.873 probability Interval 0.826 to 0.908

PRIMARY outcome

Timeframe: 1, 12 and 24 months

Population: Participant limbs treated

Revascularization for restenosis or occlusion of the target lesion. Kaplan-Meier estimates created for each time point.

Outcome measures

Measure	GORE® VIABAHN® Endoprosthesis n=324 limbs Participants with symptomatic peripheral arterial disease in superficial femoral artery lesions. GORE® VIABAHN® Endoprosthesis: Participants receiving the GORE® VIABAHN® Endoprosthesis
Freedom From Target Lesion Revascularization 1 Month	0.997 probability Interval 0.978 to 1.0
Freedom From Target Lesion Revascularization 12 Months	0.924 probability Interval 0.887 to 0.949
Freedom From Target Lesion Revascularization 24 Months	0.844 probability Interval 0.797 to 0.881

PRIMARY outcome

Timeframe: Procedure day, 1, 12, 24, 36, 48 and 60 months

Population: Participants must have been followed for at least as long as the start day identified for the time period. Participants that discontinued prior to the start day of the time period were not included in the number analyzed.

The number and proportion of the subjects for whom the occurrence of serious adverse events were reported.

Outcome measures

Measure	GORE® VIABAHN® Endoprosthesis n=321 Participants Participants with symptomatic peripheral arterial disease in superficial femoral artery lesions. GORE® VIABAHN® Endoprosthesis: Participants receiving the GORE® VIABAHN® Endoprosthesis
Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies Procedure (Day 0)	7 Participants
Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies 1 Month (Days 0 through 37)	11 Participants
Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies 3 Months (Days 38 through 121)	3 Participants
Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies 6 Months (Days 122 through 212)	9 Participants
Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies 12 Months (Days 213 through 395)	17 Participants
Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies 24 Months (Days 396 through 760)	20 Participants
Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies 36 Months (Days 761 through 1277)	13 Participants
Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies 48 Months (Days 1278 through 1642)	7 Participants
Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies 60 Months (Days 1643 through 1855)	2 Participants

PRIMARY outcome

Timeframe: Month 12, 24, 36, 48 and 60

Population: Includes all subjects who had an x-ray to determine device stent fracture status at the reported corresponding follow-up time period.

The number and proportion of stent fracture as assessed by Core lab

Outcome measures

Measure	GORE® VIABAHN® Endoprosthesis n=321 Participants Participants with symptomatic peripheral arterial disease in superficial femoral artery lesions. GORE® VIABAHN® Endoprosthesis: Participants receiving the GORE® VIABAHN® Endoprosthesis
Number of Participants With a Stent Fracture 12 Months	0 Participants
Number of Participants With a Stent Fracture 24 Months	0 Participants
Number of Participants With a Stent Fracture 36 Months	0 Participants
Number of Participants With a Stent Fracture 48 Months	0 Participants
Number of Participants With a Stent Fracture 60 Months	0 Participants

Adverse Events

GORE® VIABAHN® Endoprosthesis

Serious events: 188 serious events

Other events: 0 other events

Deaths: 85 deaths

Serious adverse events

Measure	GORE® VIABAHN® Endoprosthesis n=321 participants at risk Participants with symptomatic peripheral arterial disease in superficial femoral artery lesions. GORE® VIABAHN® Endoprosthesis: Participants receiving the GORE® VIABAHN® Endoprosthesis
Blood and lymphatic system disorders Pancytopenia	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Cardiac disorders Acute myocardial infarction	0.62% 2/321 • Number of events 2 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Cardiac disorders Acute on chronic heart failure	0.93% 3/321 • Number of events 3 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Cardiac disorders Angina pectoris	0.93% 3/321 • Number of events 3 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Cardiac disorders Aortic valve stenosis	0.93% 3/321 • Number of events 3 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Cardiac disorders Arrhythmia	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Cardiac disorders Atrial fibrillation paroxysmal	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Cardiac disorders Cardiac failure	1.6% 5/321 • Number of events 6 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Cardiac disorders Cardiac failure acute	1.2% 4/321 • Number of events 4 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Cardiac disorders Cardiac failure aggravated	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Cardiac disorders Cardiac failure chronic	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Cardiac disorders Cardiac failure congestive	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Cardiac disorders Cardiac valvulopathy	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Cardiac disorders Cardio-respiratory arrest	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Cardiac disorders Cardiogenic shock	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Cardiac disorders Coronary artery stenosis	0.93% 3/321 • Number of events 5 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Cardiac disorders Ischaemic heart disease	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Cardiac disorders Left anterior descending coronary artery stenosis	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Cardiac disorders Myocardial infarction	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Cardiac disorders Ventricular tachycardia	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Gastrointestinal disorders Gastric perforation	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Gastrointestinal disorders Intestinal obstruction	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Gastrointestinal disorders Large intestine polyp	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Gastrointestinal disorders Mesenteric arterial occlusion	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Gastrointestinal disorders Mesenteric artery stenosis	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Gastrointestinal disorders Retroperitoneal haematoma	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.62% 2/321 • Number of events 2 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
General disorders Arterial stent occlusion	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
General disorders Death	3.7% 12/321 • Number of events 12 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
General disorders Found dead (cause undetermined)	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
General disorders In-stent arterial restenosis	0.62% 2/321 • Number of events 4 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
General disorders In-stent arterial stenosis	2.2% 7/321 • Number of events 11 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
General disorders In-stent coronary artery restenosis	0.62% 2/321 • Number of events 2 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
General disorders Inflammatory reaction	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
General disorders Pyrexia	0.62% 2/321 • Number of events 2 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
General disorders Stent restenosis	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
General disorders Sudden arrhythmic death syndrome	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
General disorders Sudden death	0.62% 2/321 • Number of events 2 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
General disorders Vascular stent-graft occlusion	1.6% 5/321 • Number of events 5 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
General disorders Vascular stent-graft stenosis	7.5% 24/321 • Number of events 29 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
General disorders Vascular stent-graft thrombosis	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
General disorders Vessel puncture site haematoma	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
General disorders Vessel puncture site haemorrhage	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Hepatobiliary disorders Cholangitis	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Hepatobiliary disorders Hepatic failure	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Immune system disorders Contrast media allergy	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Infections and infestations COVID-19 pneumonia	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Infections and infestations Cystitis	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Infections and infestations Endocarditis infective	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Infections and infestations Gangrene	1.2% 4/321 • Number of events 4 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Infections and infestations Panperitonitis	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Infections and infestations Pneumonia	3.1% 10/321 • Number of events 13 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Infections and infestations Pneumonia aspiration	1.9% 6/321 • Number of events 6 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Infections and infestations Pneumonia bacterial	0.62% 2/321 • Number of events 2 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Infections and infestations Postoperative wound infection	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Infections and infestations Pyelonephritis	0.62% 2/321 • Number of events 3 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Infections and infestations Sepsis	0.62% 2/321 • Number of events 2 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Infections and infestations Septic shock	0.31% 1/321 • Number of events 2 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Infections and infestations Urinary tract infection	0.31% 1/321 • Number of events 2 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Infections and infestations Vascular stent graft infection	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Injury, poisoning and procedural complications Acute subdural haematoma	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Injury, poisoning and procedural complications Arterial bypass occlusion	0.93% 3/321 • Number of events 4 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Injury, poisoning and procedural complications Arterial bypass stenosis	0.31% 1/321 • Number of events 2 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Injury, poisoning and procedural complications Arterial injury	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Injury, poisoning and procedural complications Arterial restenosis	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Injury, poisoning and procedural complications Brain contusion	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Injury, poisoning and procedural complications Compression fracture	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Injury, poisoning and procedural complications Coronary artery reocclusion	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Injury, poisoning and procedural complications Coronary artery restenosis	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Injury, poisoning and procedural complications Femoral artery pseudoaneurysm	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Injury, poisoning and procedural complications Femoropopliteal artery bypass occlusion	0.31% 1/321 • Number of events 2 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Injury, poisoning and procedural complications Fracture	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Injury, poisoning and procedural complications Lower limb fracture	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Injury, poisoning and procedural complications Plaque shift	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Injury, poisoning and procedural complications Popliteal artery pseudoaneurysm	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Injury, poisoning and procedural complications Pseudoaneurysm	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Injury, poisoning and procedural complications Superficial femoral arterial restenosis	0.93% 3/321 • Number of events 4 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Injury, poisoning and procedural complications Tibia fracture	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Injury, poisoning and procedural complications Trochanteric femoral fracture	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Investigations Ankle brachial index decreased	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Investigations Neutrophil count decreased	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Investigations Nutritional condition abnormal	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Metabolism and nutrition disorders Geromarasmus	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Metabolism and nutrition disorders Hyperkalaemia	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Musculoskeletal and connective tissue disorders Knee deformity	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Advanced lung cancer	0.62% 2/321 • Number of events 2 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain tumour	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinomatous peritonitis	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large intestine carcinoma	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liver tumour	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer	1.9% 6/321 • Number of events 6 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer recurrent	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Nervous system disorders Bilateral recurrent laryngeal nerve paralysis	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Nervous system disorders Cardioembolic stroke	0.62% 2/321 • Number of events 2 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Nervous system disorders Cerebral haemorrhage	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Nervous system disorders Cerebral infarction	1.9% 6/321 • Number of events 6 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Nervous system disorders Epileptiform fits NOS	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Nervous system disorders Internal carotid artery stenosis	0.62% 2/321 • Number of events 2 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Nervous system disorders Lacunar infarction	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Product Issues Device occlusion	14.0% 45/321 • Number of events 60 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Psychiatric disorders Suicide	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Renal and urinary disorders Renal failure	0.62% 2/321 • Number of events 2 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Renal and urinary disorders Urinary bladder haemorrhage	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Respiratory, thoracic and mediastinal disorders Bilateral pleural effusion	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Respiratory, thoracic and mediastinal disorders COPD exacerbation	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Respiratory, thoracic and mediastinal disorders Interstitial pneumonia	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Respiratory, thoracic and mediastinal disorders Interstitial pneumonia aggravated	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Skin and subcutaneous tissue disorders Digital ulcer	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Skin and subcutaneous tissue disorders Ischaemic leg ulcer	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Skin and subcutaneous tissue disorders Lower extremities ulcers of	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Surgical and medical procedures Leg amputation	0.62% 2/321 • Number of events 2 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Surgical and medical procedures Peripheral artery stent insertion	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Vascular disorders Abdominal aortic aneurysm	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Vascular disorders Aortic aneurysm rupture	0.62% 2/321 • Number of events 2 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Vascular disorders Arterial occlusion	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Vascular disorders Arterial stenosis leg	0.62% 2/321 • Number of events 2 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Vascular disorders Arteriosclerosis obliterans	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Vascular disorders Claudication	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Vascular disorders Critical limb ischaemia	0.62% 2/321 • Number of events 2 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Vascular disorders Dialysis hypotension	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Vascular disorders Femoral arterial stenosis	0.93% 3/321 • Number of events 3 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Vascular disorders Femoral artery occlusion	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Vascular disorders Iliac artery dissection	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Vascular disorders Iliac artery occlusion	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Vascular disorders Iliac artery stenosis	1.6% 5/321 • Number of events 5 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Vascular disorders Intermittent claudication	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Vascular disorders Lower limb ischaemia	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Vascular disorders Obstructive arteriosclerosis of lower extremities	1.9% 6/321 • Number of events 8 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Vascular disorders Peripheral embolism	0.62% 2/321 • Number of events 2 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Vascular disorders Popliteal artery occlusion	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Vascular disorders Shock haemorrhagic	0.93% 3/321 • Number of events 3 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Vascular disorders Subclavian artery stenosis	0.62% 2/321 • Number of events 2 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Vascular disorders Superficial femoral arterial stenosis	2.5% 8/321 • Number of events 10 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Vascular disorders Superficial femoral artery occlusion	5.6% 18/321 • Number of events 18 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Vascular disorders Thoracic aortic aneurysm	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Vascular disorders Tibial artery occlusion	0.62% 2/321 • Number of events 2 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Vascular disorders Tibial artery stenosis	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
Vascular disorders Vascular dissection	0.31% 1/321 • Number of events 1 • 60 months (Days 0 through 1855) The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.

Other adverse events

Adverse event data not reported

Additional Information

Eric Novak

W. L. Gore & Associates

Phone: 314-440-2110

Email: enovak@wlgore.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PI is required to obtain written permission from the Sponsor prior to publishing trial results.
• Publication restrictions are in place

Restriction type: OTHER