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

Catalog Number	PLL161207
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	12/05/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Concomitant medical products - patient medications: aspirin, coreg, clonidine, chlorthalidone, januvia, metformin, glipizide, breo ellipta, and benicar.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Per the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to death.
Event or Problem Description
On (b)(6) 2019, the patient was implanted with a gore® excluder® aaa endoprosthesis and several gore® viabahn® endoprostheses to treat aortoiliac occlusive disease also known as cerab.The gore® excluder® aaa endoprosthesis was implanted in the infrarenal aorta towards the aortic bifurcations and then the physician implanted gore® viabahn® endoprostheses bilaterally in both common iliac arteries to give inflow distally to keep arteries open for distal bi-passes in the legs.The patient tolerated the procedure.It was reported the patient expired on (b)(6) 2019, due to bowel ischemia.The physician stated that he felt the cause of the bowel ischemia was due to an embolic event or the covering of the internal mesenteric artery, which was planned.The cause of the bowel ischemia is unknown, there was no post mortem autopsy performed.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9545355
• Report Number: 3013164176-2020-00002
• Device Sequence Number: 2334181
• Product Code: MIH
• UDI-Device Identifier: 00733132618798
• UDI-Public: 00733132618798
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2019

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: 12/17/2021
• Device Catalogue Number: PLL161207
• Device Lot Number: 20014610
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2020
• 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: Death
• Patient Age: 57 YR
• Patient Weight: 79