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

Model Number	PLC141200
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight: asked but unavailable 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, improper component placement.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.The ifu also instructs users to use fluoroscopic visualization for all guidewire, sheath, and device catheter manipulations.
Event or Problem Description
On (b)(6) 2020 the patient underwent endovascular treatment of an abdominal aortic aneurysm and an iliac artery aneurysm using gore® excluder® aaa endoprostheses.The gore field sales associate was present for the case at southeastern medical center.It was noted that visualization of the gore device was extremely difficult during the procedure as there was a previously placed endologix device with an additional layer of endologix cuff.The endologix devices were reportedly placed on an unknown date.It was reported that, due to the poor visualization, there was no evidence of any unintentional device placement during the index procedure.On an unknown date the patient was seen at duke university hospital.An axillary to femoral bypass was performed and the previous gore® excluder® aaa contralateral leg component was occluded using occluder plugs.The gore representative became aware of the reintervention on (b)(6) 2021 and reported that, in reviewing imaging, it was apparent that the gore® excluder® aaa contralateral leg component had been deployed outside of the contralateral leg gate of the trunk-ipsilateral leg component.The unintentional device placement was attributed to the poor visualization during the index procedure.There were no further reported issues.The patient tolerated the reintervention and was discharged to home on an unknown date.

• 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13293566
• Report Number: 3013164176-2022-01286
• Device Sequence Number: 4547421
• Product Code: MIH
• UDI-Device Identifier: 00733132618675
• UDI-Public: 00733132618675
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 01/19/2022

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: 01/10/2023
• Device Model Number: PLC141200
• Device Catalogue Number: PLC141200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2021
• Initial Report FDA Received Date: 01/19/2022
• Date Device Manufactured: 01/11/2020
• 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: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female