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

Catalog Number	PXT261412
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2013, the patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.Trunk-ipsilateral leg (pxt261412/(b)(4)) and two contralateral leg components were successfully deployed.The patient tolerated the procedure.Later in a follow-up study, a type ii endoleak was confirmed.Aneurysm diameter increased up to 70mm.As aneurysm diameter at the time of initial implant procedure was not available, exact amount of enlargement was unknown.On (b)(6) 2018, first-stage reintervention was performed whereby a contralateral leg component and a bare-metal stent were implanted in the right external iliac artery.The right internal iliac artery was intentionally embolized.On (b)(6) 2018, second-stage reintervention was performed whereby a contralateral leg component and a bare-metal stent were implanted in the left external iliac artery.The left internal iliac artery was intentionally embolized.Type ii endoleak was resolved, and the patient tolerated the reintervention procedure.
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to endoleak and aneurysm enlargement.

• 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: 8098041
• Report Number: 3007284313-2018-00329
• Device Sequence Number: 11166885
• Product Code: MIH
• UDI-Device Identifier: 00733132610211
• UDI-Public: 00733132610211
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2018

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: 01/31/2016
• Device Catalogue Number: PXT261412
• Device Lot Number: 11136402
• 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: 11/21/2018
• Supplement Report FDA Received Date: 11/27/2018
• 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; Required Intervention
• Patient Age: 87 YR