The primary safety endpoint event includes a composite of the following:

• Death
• Stroke
• Myocardial Infarction
• Bowel Ischemia
• Paraplegia
• Respiratory Failure
• Renal Failure
• Procedural Blood Loss > 1000 mL
• Thromboembolic events (including limb occlusion and distal embolic events)

This population consists of subjects with a physical exam follow-up visit at or after 30 days following CEXC device implant procedure. Additionally, any subjects with an eligible safety event, even if they did not complete a follow-up visit at or after 30 days following implant procedure, were included.

The Primary Effectiveness Endpoint of device treatment success is a composite of technical success (successful access and deployment of all required GORE® EXCLUDER® Conformable AAA Endoprosthesis components) and freedom from:

• Type I endoleak in the 12 month window
• Type III endoleak in the 12 month window
• Migration (10 mm or more) at the 12 month window (relative to post-operative baseline)
• AAA enlargement ≥5 mm with or without intervention at the 12 month window (relative to post-operative baseline)
• AAA rupture through the 12 month window
• Conversion to open repair through the 12 month window

This population consists of subjects with both a post-op contrast-enhanced CT (CTA) and a 12-Month CTA. Additionally, any subjects with an eligible effectiveness event, even if they did not complete the necessary follow-up visit or imaging to otherwise be included in the population, were included.

Defined as an adverse event treatment performed to either treat the abdominal aneurysm and/or device-related complication (Adjudicated by independent Clinical Events Committee)

Defined as fracture of the wire used to construct the stent (assessed by independent 3rd party imaging laboratory)

Defined as an endoleak arising from a patent branch vessel perfusing the aneurysm, e.g., lumbar or inferior mesenteric branch. (assessed by independent 3rd party imaging laboratory)

Defined as a composite of the following: death within 30 days or in hospital from initial procedure, death due to rupture of the originally treated aneurysm and death within 30 days or in hospital following a procedure to treat the originally treated aneurysm. (Adjudicated by independent Clinical Events Committee)

Defined as estimated blood loss recorded during the endovascular procedure > 1000 mL

Subjects with non-missing procedural blood loss

Defined as Endoleak of whole blood through the graft fabric (Graft Porosity). (assessed by independent 3rd party imaging laboratory)

Defined as time to discharge for initial procedural hospitalization

All enrolled subjects

Defined as time from first arterial access in the groin to the closure of the final access vessel

All enrolled subjects

Defined as stroke resulting in severe impairment or fatal outcome (Adjudicated by independent Clinical Events Committee)

Defined as myocardial Infarction resulting in severe hemodynamic dysfunction necessitating resuscitation, cardiac arrest, or fatal outcome. (Adjudicated by independent Clinical Events Committee)

Defined as bowel Ischemia resulting in bowel resection or fatal outcome (Adjudicated by independent Clinical Events Committee)

Paraplegia resulting in major permanent deficit (Adjudicated by independent Clinical Events Committee)

Defined as death of any cause (all-cause mortality)

Defined as renal failure resulting in permanent dialysis, transplant, or fatal outcome (Adjudicated by independent Clinical Events Committee)

Defined as respiratory failure resulting in prolonged intubation (> 48 hours), tracheostomy, deterioration in pulmonary function, new onset O2 dependence, or fatal outcome (Adjudicated by independent Clinical Events Committee)

Defined as ischemic events from tissues distal to the device implantation site (lower extremity, buttock, etc.) and that are a direct result of an occlusion within the device or sufficiently debilitating to necessitate bypass, open surgical repair, or limb amputation (Adjudicated by independent Clinical Events Committee)

Defined as endoleak arising from the proximal (Type IA) or distal (Type IB) sealing zone of the device perfusing the aneurysm. (assessed by independent 3rd party imaging laboratory)

Defined as endoleak arising from the component junction(s) of the prosthesis or due to damage to the graft material (assessed by independent 3rd party imaging laboratory)

Defined as prosthesis and/or intercomponent migration (10 mm or more) relative to post-operative baseline (assessed by independent 3rd party imaging laboratory)

Median blood loss at index procedure

Number of subjects with non-missing blood loss

Defined as AAA enlargement ≥5 mm (with or without reintervention) relative to post-operative baseline (assessed by independent 3rd party imaging laboratory)

Defined as rupture in the treated segment of the aorta verified with direct observation or CT scan

Defined as open surgical abdominal aneurysm repair necessitating the explant of the stent-graft and abdominal aortic reconstruction (Adjudicated by independent Clinical Events Committee)

Successful access and deployment of all required CEXC device components, comprised of all the following:

• Successful access
• Successful deployment of Device endoprostheses in the intended anatomical location
• Successful removal of all device delivery catheters from the patient
• Patent Device components on completion angiography
• Absence of Type I or Type III endoleak on completion angiography
• Successful access site closure

All enrolled subjects