MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	PXC201200
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/19/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the instructions for use (ifu) for the gore® excluder® aaa endoprostheses; adverse events that may occur include, but are not limited to include: endoleak a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.
Event or Problem Description
On (b)(6) 2011, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses.The patient tolerated the procedure.On an unknown date, estimated to be on or about (b)(6) 2011; enlargement of the right common iliac artery was noted and thought to be due to the distal end of the contralateral leg component appearing to lack circumferential apposition to the vessel wall.On (b)(6) 2019, the patient underwent re-intervention and an additional stent graft was implanted to extend the coverage to the right external iliac artery, with intentional coverage of the right internal iliac artery.It was reported that no embolization of the patient¿s right internal iliac artery was performed as the patient had a pre-existing stenosis of the right internal iliac artery.The patient tolerated the procedure with two type ii endoleaks noted from unknown sources at the conclusion.The physician will monitor the type ii endoleaks.
Additional Manufacturer Narrative
B7: supplemental medwatch submitted to include patient medical history which did not transmit to fda electronically as transmitted.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9013537
• Report Number: 2017233-2019-00854
• Device Sequence Number: 19452188
• Product Code: MIH
• UDI-Device Identifier: 00733132610044
• UDI-Public: 00733132610044
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2013
• Device Catalogue Number: PXC201200
• Device Lot Number: 8537256
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 75 YR