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

Model Number	RLT281416
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/02/2021
Type of Reportable Event	Serious Injury
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, adverse events that may occur and/or require intervention include, but are not limited to, infection.This event also includes device 22029639/00733132618637, 21749858/00733132618613 and 21855351/ 00733132618644.
Event or Problem Description
On (b)(6) 2020, the patient was treated for an abdominal aortic aneurysm.A gore® excluder® aaa endoprosthesis featuring c3® delivery system and three gore® excluder® aaa endoprostheses.The patient tolerated the procedure.On (b)(6) 2021, the patient underwent a procedure to remove the devices due to infection.The cause of the infection is unknown.

• 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
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11254794
• Report Number: 3007284313-2021-01236
• Device Sequence Number: 3532847
• Product Code: MIH
• UDI-Device Identifier: 00733132622542
• UDI-Public: 00733132622542
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2022

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: 12/01/2022
• Device Model Number: RLT281416
• Device Catalogue Number: RLT281416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male