MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	RLT231216
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Post Operative Wound Infection (2446)
Date of Event	09/26/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The review of the manufacturing and sterilization paperwork verified that these lots met all pre-release specifications.Another gore® excluder® aaa endoprosthesis was explanted during the procedure: plc121000/17520361, udi# (b)(4).The gore® excluder® aaa endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (aaa) disease.The safety and effectiveness of the gore® excluder® aaa endoprosthesis have not been evaluated in the following patient populations: leaking: pending rupture or ruptured aneurysms.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 bleeding, infection (e.G., aneurysm, device or access sites), aneurysm rupture, surgical conversion and death.
Event or Problem Description
On (b)(6) 2018, gore® excluder® aaa endoprostheses were implanted in a patient with a ruptured aorta due to an abdominal ulcer which occurred during a previous fluoroscopic procedure.Reportedly, the procedure was completed within the gore® excluder® aaa endoprosthesis instructions for use (ifu), without any complications, and the patient tolerated the procedure.It was reported that one month after the procedure was completed, the patient had bleeding due to a failed percutaneous access site and underwent a procedure to treat the bleeding.Infection was found in the site of the percutaneous access after the bleeding was treated.According to the physician, infection was not related with gore® excluder® aaa endoprostheses and after the treatment, it appeared that the infection did not spread.It was reported that on (b)(6) 2018, the patient was diagnosed with continued infection with the pain in the zone that was not covered by the gore device implants.Also, it was noticed a new aneurysm developed (a zone of 3-4mm) and it ruptured.On (b)(6) 2018, the physician planned to treat the new rupture with a dacron graft.There was no problem with the graft anastomoses; however, since it was at the level of the renal arteries, the graft could not be implanted.The physician performed a conversion and all devices were explanted.Later that day, the patient had complications of the surgery that were unrelated to the gore devices.According to the physician, the complication was that the infection made the anastomosis difficult in the visceral branches and the patient lost a lot of blood.The patient went to the intensive care unit where they died after a couple of hours.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8040336
• Report Number: 3007284313-2018-00307
• Device Sequence Number: 11088446
• Product Code: MIH
• UDI-Device Identifier: 00733132622344
• UDI-Public: 00733132622344
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/10/2018

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: 08/14/2020
• Device Catalogue Number: RLT231216
• Device Lot Number: 16601735
• 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: 11/05/2018
• 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: Death; Hospitalization; Other; Required Intervention
• Patient Age: 85 YR