Post-Approval Study of the TREO Abdominal Stent-Graft System

Incidence of fracture in a stent-strut or separation of one or more proximal fixation barbs as confirmed by the Imaging Core Laboratory upon review of post-implant imaging studies.

Incidence of secondary intervention for adverse events related to or caused as a result of a fracture in a stent-strut or separation of one or more proximal fixation barbs. Relatedness to the device will be confirmed by the Clinical Events Committee (CEC) through review of available treatment and procedure records and reports of imaging studies.

Defined as the following:

• successful delivery (i.e., ability to deliver the implant to the intended location without the need for unanticipated corrective intervention related to delivery);
• successful and accurate deployment (deployment of the endovascular stent graft in the planned location; patency of the endovascular stent graft, absence of device deformations such as kinks, stent eversion, mal-deployment, misaligned deployment, requiring unplanned placement of an additional device within the endovascular stent graft, and
• successful withdrawal (i.e. successful withdrawal of the delivery system, without the need for unanticipated corrective intervention related to withdrawal)

Incidence of the following Major Adverse Events

• Myocardial infarction according to SCAI definition
• Stroke according to the VARC-2 guidelines
• New Onset Renal Failure requiring permanent dialysis
• New onset Respiratory Failure requiring permanent home oxygen therapy through 30 days
• Permanent Paralysis/Paraplegia
• Bowel Ischemia
• Procedural blood loss (≥ 1000cc)

Reporting of procedural data collected during implant of the TREO Abdominal Stent-Graft System including: Procedure time (minutes), Fluoroscopy time (minutes), Contrast volume (mL), Access method (i.e. percutaneous, surgical cut down), Length of ICU stay (hours), Length of hospital stay post-procedure (days), Anesthesia Type.

Incidence of adverse events occurring during or following the implant determined by the CEC to be procedure-related.

Successful aneurysm treatment is defined as:

• Technical success
• Absence of death from the initial procedure, secondary intervention or aortic-related cause.
• Absence of persistent type I or III endoleaks
• Absence of aneurysm sac expansion >5 mm
• Absence of device migration >10mm
• Absence of failure due to device integrity issues
• Absence of aneurysm rupture
• Absence of conversion to open surgical repair
• Absence of permanent paraplegia, disabling stroke or dialysis that resulted from the initial operation or a secondary intervention to treat the original aortic pathology.

Rate of mortality attributed to any causality as confirmed by the CEC.

Rate of mortality attributed to the following causes as confirmed by the CEC: death due to a rupture, death within 30 days or prior to hospital discharge from primary procedure, or death within 30 days or prior to hospital discharge for a secondary procedure designed to treat the original aneurysm.

Incidence of rupture of the native aneurysm sac post-implantation of the endograft as confirmed by the CEC.

Incidence of secondary procedures designed to treat or repair the original aneurysm treated with the TREO Abdominal Stent-Graft System

Incidence of conversion to open surgical AAA repair during the initial EVAR procedure secondary to any procedure-related complications as determined by the CEC.

Incidence of stent-graft occlusion defined as the unintentional obstruction of the vascular/endograft lumen with minor obstruction (0-25%), minimal obstruction (26-74%), moderate obstruction (75-99%) or occlusion (100%) as confirmed by the Imaging Core Lab due to causes such as twisting or kinking of the prosthesis, oversizing and fabric pleating, or failure of the implant to fully open, or to mural thrombus deposition.

Incidence of stenosis or kinking of the TREO Stent-Graft as confirmed by the Imaging Core Lab.

Incidence of changes in the structural integrity in a material component of the stent-graft such as a stent-strut fracture or separation of the proximal fixation barbs as confirmed by the Imaging Core Lab.

Incidence of the increase in the aneurysm sac diameter > 5 mm at post-implant follow-up visits relative to the diameter determined at the first post-procedural imaging study, as confirmed by the Imaging Core Lab.

Incidence of the longitudinal movement of all or part of a stent or attachment system for a distance of >10 mm relative to anatomical landmarks that were determined at the first post-procedural imaging study as confirmed by the Imaging Core Lab.

Incidence of Type I, II, III, IV or V Endoleaks defined as the persistence of blood flow outside the lumen of the stent-graft but within the native aorta or adjacent vascular segment being treated by the stent-graft as determined by the Imaging Core Lab.