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

Model Number	PLC121200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	03/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: (b)(4).The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states, adverse events that may occur and / or require intervention include but are not limited to: infection (e.G., aneurysm, device or access sites), surgical cut down, bypass or conversion.
Event or Problem Description
On (b)(6) 2020, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses featuring c3® delivery system.The patient tolerated the procedure.On (b)(6) 2021, the patient underwent reintervention for an infection of the devices caused by the development of an aortoduodenal fistula (adf).The devices were explanted and an axillobifemoral bypass was performed.The adf was not thought to have been pre-existing at the time of original implant.The patient tolerated the procedure.The explanted devices were retained by the site and will be returned to gore for analysis.
Additional Manufacturer Narrative
The explanted devices were returned to gore for analysis and showed the following: submitted unfixed, was a gore excluder aaa endoprostheses system; one trunk ¿ ipsilateral leg endoprosthesis (trunk) and one contralateral leg endoprosthesis (cl).The abluminal surfaces were generally devoid of tissue, except for scattered plaques of soft red/pink tissue.The lumens were generally devoid of tissue, except for scattered plaques of soft red/pink tissue.The lumens of both devices were widely patent.The devices were not properly stored in a fixative solution for proper preservation of the tissue on and within the devices.Therefore, a histopathological examination of the tissue could not be performed, due to the lack of proper fixation prior to arrival at w.L.Gore & associates.The devices were subjected to an enzymatic digestion process to remove biologic debris.Following digestion all devices were examined for material disruptions with the aid of a stereomicroscope and sem imaging.An area of radial film disruption on cl and one hole on the trunk were identified, which were consistent with in-vivo wear.Other material disruptions identified (i.E., black-charred/melted material), were consistent with those cause by interaction with surgical instrumentation (i.E., electrocautery), likely used during the explant 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: 11734748
• Report Number: 3013164176-2021-01148
• Device Sequence Number: 3309320
• Product Code: MIH
• UDI-Device Identifier: 00733132618712
• UDI-Public: 00733132618712
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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: 09/22/2023
• Device Model Number: PLC121200
• Device Catalogue Number: PLC121200
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 08/30/2021
• 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: Other; Required Intervention; Disability
• Patient Age: 68 YR