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

Model Number	PLC161000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that the lot met all pre-release specifications.
Event or Problem Description
The following was reported to gore: on (b)(6) 2020 this patient underwent endovascular treatment using gore® excluder® aaa endoprostheses.It was recorded in the medical device tracking system that the gore® excluder® aaa endoprostheses contralateral leg component was explanted and destroyed on the day of implant.The reason for explant is unknown.
Additional Manufacturer Narrative
D1: brand name corrected.
Additional Manufacturer Narrative
Conclusion code updated - all requests for information regarding the reason for explant have been exhausted.The physician states he has no further records or comments regarding the event.As no additional information will be provided regarding explant procedure and no additional investigation can be performed, the event will be closed with the provided information.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10066686
• Report Number: 3013164176-2020-00067
• Device Sequence Number: 777525
• Product Code: MIH
• UDI-Device Identifier: 00733132618668
• UDI-Public: 00733132618668
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2020

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: 11/17/2022
• Device Model Number: PLC161000
• Device Catalogue Number: PLC161000
• Device Lot Number: 21349783
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/18/2020
• Supplement Report FDA Received Date: 09/07/2020; 09/09/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR