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

Model Number	PLC271400
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was treated with a gore® excluder® conformable aaa endoprosthesis on (b)(6) 2019.On (b)(6) 2022, the endoprosthesis was explanted due to infection.The infection originated in the psoas muscle, which caused an abscess and eventual spread to the endoprosthesis.The infection did not predate the implantation.
Additional Manufacturer Narrative
The device is currently at the explant facility for culture testing.Medical device: gore® excluder® conformable aaa endoprosthesis (b)(4).The production records for the implanted devices are currently being reviewed.The instructions for use state: "adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to infection (e.G.Aneurysm, device or access sites).".

• 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: tom hormby ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15000136
• Report Number: 3013164176-2022-01430
• Device Sequence Number: 13852301
• Product Code: MIH
• UDI-Device Identifier: 00733132618606
• UDI-Public: 00733132618606
• 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: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2022

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: 01/11/2022
• Device Model Number: PLC271400
• Device Catalogue Number: PLC271400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 89 KG