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

Catalog Number	PLC141400
Medical Device Problem Codes	Structural Problem (2506); Device Stenosis (4066)
Health Effect - Clinical Codes	Stenosis (2263); Thrombosis/Thrombus (4440)
Date of Event	06/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2025, patient underwent an endovascular aneurysm repair (evar) procedure to treat an abdominal aortic aneurysm utilizing gore® excluder® aaa endoprosthesis.Reportedly, the procedure went well with final angio run looking good and there were no anatomical challenges.On (b)(6) 2025, physician did a reintervention by doing a fem-fem bypass and patient tolerated procedure.Field sales associate (fsa) was not present for the procedure.Reintervention was due to the left limb being crushed at the bifurcation and cause is unknown after looking at the scans.It is also unknown if they tried to fix it endovascularly or not as physician only conveyed, they fixed the issue via fem-fem bypass.There were no anatomical challenges.
Additional Manufacturer Narrative
H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.Imaging evaluation summary: the imaging evaluation performed by a clinical imaging specialist showed the following: ¿a pre and post dicom ct imaging was provided for analysis ¿the post dicom imaging shows a stenosis of the left leg at the level of the aortic bifurcation.Confirming the statement in the report.¿the post left leg also appears to have thrombus present.¿the post dicom imaging also shows slight narrowing of the right leg at the level of the aortic bifurcation.¿the pre dicom shows an aortic bifurcation measuring approximately 12mm.¿the pre also shows an irregular flow lumen in the proximal lci.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Additional Manufacturer Narrative
Added g3/g4, h1/h2, h6.

• 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: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22546957
• Report Number: 3013164176-2025-02608
• Device Sequence Number: 8614946
• Product Code: MIH
• UDI-Device Identifier: 00733132618651
• UDI-Public: (01)00733132618651(17)280225
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PLC141400
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male