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

Model Number	PLC231400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #plc201000/ serial #(b)(4) / udi #(b)(4).Which is captured in manufacturer report #3013164176-2021-01172.Patient weight: asked but unavailable.Date of event: as the date of identification of the infection is unknown, but was reported as about one month after the intervention procedure, and as the device explant was performed on (b)(6) 2021, the event date has been estimated as (b)(6) 2021.Concomitant medical products and therapy dates: asked but unavailable according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure related 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).Furthermore, the ifu states that the safety and effectiveness of the gore® excluder® aaa endoprosthesis have not been evaluated in patient populations including, but not limited to, revision of previously placed stent grafts.
Event or Problem Description
On (b)(6) , 2021 the patient underwent reintervention of a previously implanted medtronic endurant¿ device due to continuing iliac artery aneurysm enlargement.It was reported that two gore® excluder® aaa contralateral leg components were implanted bilaterally.There were no reported issues with the bilateral limb extension.The patient tolerated the procedure.On or about (b)(6) 2021 (reported as about one month after the reintervention procedure) the patient presented with an infection.It was reported that the patient did not have a pre-existing infection prior to the reintervention on (b)(6) 2021.The physician did not report any allegations of deficiency against the gore devices, but noted that the cause of the infection was unknown.On (b)(6) 2021 all devices were explanted.A rifampin antibiotic soaked open replacement graft was implanted.The devices were discarded.There were no further reported issues.The patient tolerated the explant.

• 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: 11807853
• Report Number: 3013164176-2021-01173
• Device Sequence Number: 3535884
• Product Code: MIH
• UDI-Device Identifier: 00733132618583
• UDI-Public: 00733132618583
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2021

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: 08/04/2023
• Device Model Number: PLC231400
• Device Catalogue Number: PLC231400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/11/2021
• 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: Required Intervention
• Patient Age: 65 YR