Evaluation of GORE® VIABAHN® Endoprosthesis for Popliteal Artery Aneurysm

The primary objective is to evaluate the safety and efficacy of the GORE® VIABAHN®
Endoprosthesis for the treatment of subjects with Popliteal Artery Aneurysms. The study
population includes subjects with an asymptomatic aneurysm (≥ 2 cm diameter) of the
popliteal artery, symptomatic aneurysm (no diameter requirement) of the popliteal artery, or
presence of mural thrombus (no diameter requirement) of the popliteal artery treated with
the GORE® VIABAHN® Endoprosthesis between January 1, 2002 and December 31, 2010. Starting
with most recently treated within the above date range, patients meeting Inclusion/Exclusion
will be enrolled, until a minimum of 50 subjects with adequate follow up to determine
primary endpoints through 12 months will be provided.

Inclusion Criteria:

- Received a GORE® VIABAHN® Endoprosthesis between January 1, 2002 and December 31,
2010 to treat a popliteal artery aneurysm;

- Had an asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, or
symptomatic aneurysm (no diameter requirement) of the popliteal artery, or the
presence of mural thrombus (no diameter requirement) of the popliteal artery;

- Was 18 years of age or older; and

- Had an elective popliteal artery aneurysm procedure.

Exclusion Criteria:

- Bilateral popliteal artery aneurysms with initial treatment on the same day

- Had previous surgery for the popliteal artery aneurysm in the study limb