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

Catalog Number	PLC181400
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	02/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, this 87-year-old male patient underwent endovascular treatment as a planned cut-down procedure for an abdominal aortic aneurysm.The patient was treated with a gore® excluder® conformable aaa endoprosthesis trunk ipsilateral leg endoprosthesis and two gore® excluder® endoprosthesis contralateral leg endoprosthesis devices.The gore® devices were successfully navigated to the intended location and successfully deployed.The sites were accessed percutaneously.Device catheters were successfully removed after successful access, delivery and deployment of the devices.He was discharged home on (b)(6) 2025.On (b)(6), 2025, the patient had a cta follow up.There was no loss of patency to any devices.It was noted that the right iliac leg component now covered the right internal iliac artery.This event is ongoing and no treatment was provided at this point.It is not known which of the devices is covering the right internal iliac.
Additional Manufacturer Narrative
It is unknown which gore® excluder® covered the right internal iliac.Additional excluder® included on this report: sn: (b)(6).Udi: ((b)(4).Catalog: plc141000.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 instructions for use, complications associated with the use of the gore® excluder® aaa endoprosthesis that may occur include, but are not limited to, occlusion of native vessels.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.

• 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: 21665270
• Report Number: 3013164176-2025-02444
• Device Sequence Number: 7625319
• Product Code: MIH
• UDI-Device Identifier: 00733132618699
• UDI-Public: (01)00733132618699(17)270106
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/21/2025

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: PLC181400
• 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: 02/27/2025
• Initial Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CHOLESTEROL AND HYPERTENSION MEDICATIONS (NOT SPEC.
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 82 KG