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

Model Number	RLT261416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, this patient underwent endovascular treatment of an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis.On an unknown date, the patient underwent implant of a pacemaker.A groin infection was identified post procedure, which was suspected to have spread to the gore® devices, demonstrated by a white blood cell scan.Therefore, on (b)(6) 2021, the patient underwent an open surgical conversion whereby the gore® devices were explanted and replaced with an aorto-bifemoral dacron graft.The patient tolerated the procedure.

• Brand Name: GORE EXCLUDER AAA 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: 12513225
• Report Number: 3007284313-2021-01592
• Device Sequence Number: 20125929
• Product Code: MIH
• UDI-Device Identifier: 00733132622467
• UDI-Public: 00733132622467
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2021

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: 02/17/2021
• Device Model Number: RLT261416
• Device Catalogue Number: RLT261416
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PXC141000/15607479, PLA280300/15047902
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR