The percentage of subjects experiencing a Major Adverse Event (MAE) within 30 days post-implantation.

MAEs include the occurrence of any of the following events:

• All-cause mortality
• Bowel ischemia
• Myocardial infarction
• Paraplegia
• Procedural blood loss ≥1000 cc
• Renal failure
• Respiratory failure
• Stroke

Globally, 4 out 139 Subjects experienced a MAE within 30 days (2.9%).

Successful aneurysm treatment was achieved based on the following criteria:

Technical success at the index procedure (as assessed intra-operatively), defined as successful delivery and deployment of the Endurant Evo AAA Stent graft system in the planned location and with no unintentional coverage of both internal iliac arteries or any visceral aortic branches and with successful removal of the delivery system AND

Treatment success consisting of freedom from:

• AAA diameter increase, defined as > 5 mm increase in maximum diameter as measured on computed tomography (CT) scan or magnetic resonance angiography/magnetic resonance imaging (MRA/MRI) at 12-month follow-up as compared to 1-month imaging
• Types I and III endoleaks at 12-month follow-up including those requiring intervention through 12 months
• Aneurysm rupture within 365 days
• Conversion to surgery within 365 days
• Stent graft migration resulting in a serious adverse event or requiring seco

While the full 139 subjects were evaluable for Technical Success at index procedure, 118 subjects were evaluable for treatment success at 12 month follow up.

All-cause mortality (ACM) within 30, 183, 365 days

At 0-365 days, 138 subjects were evaluable

Aneurysm-related mortality (ARM) within 30, 183, and 365 days

In 0-365 days, 133 subjects were evaluable for Aneurysm related mortality

Any reintervention procedure (surgical or endovascular) following the completion of the operative initial implantation procedure that is used to correct a Type I and III endoleaks within 183 and 365 days. Type I endoleak was defined as a leak resulting from an incomplete seal of the endograft proximally or distally and a Type III endoleak was defined as a leak resulting from a defect of fabric or between the segments of the modular graft (junctional endoleak.

In 0-183 days, 138 subjects were evaluable In 0-365 days, 132 subjects were evaluable

Secondary procedures within 183 and 365 days

In 0-183 days, 138 subjects were evaluable In 0-365 days, 134 subjects were evaluable

Serious adverse events within 30, 183 and 365 days.

Conversion to open surgery within 183, and 365 days

In 0-183 days, 138 subjects were evaluable In 0-365 days, 133 were evaluable

Aneurysm rupture within 183 and 365 days

In 0-183 days, 138 subjects were evaluable In 0-365 days, 132 subjects were evaluable

Major adverse events within 183 and 365 days

In 0-183 days, 139 subjects were evaluable In 0-365 days, 138 subjects were evaluable

Stent graft movement of either the main body or iliac limb distally or proximally at 6- and 12-month follow-up visits (as compared to 1-month imaging). Main body stent graft migration is defined as evidence of movement of the main body stent graft relative to fixed anatomic landmarks, which is not due to remodeling of the subject's vasculature. Migration is observed when the stent graft completely covers a renal artery or movement is > 10 mm either distally or proximally. Stent graft limb/extension migration is defined as evidence of a movement of the stent graft limbs/extensions relative to fixed anatomic landmarks, which is not due to remodeling of the subject's vasculature that is > 10 mm or coverage of the internal iliac artery.

At 6-months, 124 subjects were evaluable At 12-months, 121 subjects were evaluable

Aneurysm expansion >5 mm at 6- and 12-month follow-up visits (as compared to 1-month imaging)

At 6-months, 130 subjects were evaluable. At 12-months, 123 subjects were evaluable.

All endoleaks based on imaging findings at 1-month, 6-month and 12-month. An endoleak is defined by the presence of contrast-enhanced blood outside the lumen of the endoluminal graft but within the aneurysm sac as seen on computed tomography (CT), angiography, ultrasound, or other appropriate imaging modality.

At 1-month 134, subjects were evaluable. At 6-months, 124 subjects were evaluable. 12-months 117 subjects were evaluable

Stent graft occlusions based on imaging findings through 1-, 6- and 12 months. Stent graft occlusion is defined as a 100% blockage of the lumen diameter of any implanted stent graft component(s) as evidenced by CT, angiography, ultrasound, or other appropriate imaging modality, and/or operative or pathological analysis.

Through 1-month, 136 subjects were evaluable. Through 6-months, 124 subjects were evaluable. Through 12-months, 120 subjects were evaluable.

Device deficiencies based on imaging findings through 6- and 12 months. A device deficiency was defined according Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance (ref. ISO 14155:2011 3.15).

Through 6-months, 125 subjects were evaluable. Through 12-months, 126 subjects were evaluable.