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

Model Number	PLC231000
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/27/2020
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 with may occur and/or require intervention including, but not limited to, endoleak.
Event or Problem Description
On (b)(6) 2020, the patient was implanted with several gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.On follow up imaging peformed on (b)(6) 2020, a type iii endoleak was discovered.The physician plans to do a reintervention to treat the endoleak.The physician believes the cause of the event was insufficient overlap between the two bridge devices.
Additional Manufacturer Narrative
G5: filled in responses to pre-1938, combination product and otc product.
Additional Manufacturer Narrative
H10/11: narrative/corrected data - additional information received 2-jul-2020.Reintervention took place to treat previously-reported type iii endoleak.Additional stent graft was implanted, and endoleak was resolved.Patient tolerated the procedure.

• 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: 10206754
• Report Number: 3013164176-2020-00087
• Device Sequence Number: 3271206
• Product Code: MIH
• UDI-Device Identifier: 00733132618576
• UDI-Public: 00733132618576
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2020

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: 12/15/2022
• Device Model Number: PLC231000
• Device Catalogue Number: PLC231000
• Device Lot Number: 21458840
• 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: 06/29/2020
• Supplement Report FDA Received Date: 07/16/2020; 08/04/2020
• 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: Required Intervention
• Patient Age: 67 YR