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

Catalog Number	PLC181000
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	02/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2025, a patient was treated for an aortic aneurysm in a highly calcified area with a gore® excluder® aaa endoprosthesis contralateral leg.After deployment, the distal edge of the device was sitting on the aortic bifurcation, but after ballooned it was moved higher.On (b)(6), the patient returned to the hospital complaining of hip pain.After performing a ct scan, the physician noted that the left common femoral artery was occluded, and the distal end of the right external iliac was thrombosed.The physician suspects that the left common femoral artery was occluded when sealing the incision for the angiograph.It is uncertain what the cause was of thrombosis in the right external iliac artery.There was not significant thrombus present in the patient.A reintervention took place to clear the thrombus and the occlusion.
Additional Manufacturer Narrative
H.6.Investigation findings code c20: the device remains implanted and is not available for analysis.H.6.Investigation findings code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H.6.Investigation conclusions code d12: it should be noted that, per the gore® excluder® aaa endoprosthesis, complications associated with the use of the gore® excluder® aaa endoprosthesis that may occur and/or require intervention include, but are not limited to, arterial thrombosis.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
There is no direct allegation against a gore device.Therefore, this mdr is being retracted.

• 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: bryce wargin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21442191
• Report Number: 3013164176-2025-02401
• Device Sequence Number: 19920734
• Product Code: MIH
• UDI-Device Identifier: 00733132618743
• UDI-Public: (01)00733132618743(17)270820
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 03/20/2025

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?: No
• Device Catalogue Number: PLC181000
• 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: 02/03/2025
• Supplement Date Received by Manufacturer: 03/01/2025
• Initial Report FDA Received Date: 02/23/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female