MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE EXCLUDERAAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	PLA230300
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Codes	Bacterial Infection (1735); Fistula (1862)
Date of Event	05/05/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the patient presented with a right common iliac artery aneurysm that was treated with the implantation of gore® excluder® aaa endoprosthesis and gore® excluder® iliac branch endoprostheses on (b)(6) 2015.On (b)(6) 2017, the patient presented with an aorto-enteric fistula and related graft infection.The devices were explanted, and a bowel resection was done.The patients died on (b)(6) 2017, due to a septic problem.

• Brand Name: GORE EXCLUDERAAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11918737
• Report Number: 2953161-2021-01063
• Device Sequence Number: 19044444
• Product Code: MIH
• UDI-Device Identifier: 00733132618750
• UDI-Public: 00733132618750
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2021

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: 04/30/2017
• Device Model Number: PLA230300
• Device Catalogue Number: PLA230300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 06/02/2021
• 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; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 72