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 Code	Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
The field sales associate (fsa) reported the following to gore: on (b)(6) 2018, the patient underwent an endovascular procedure to utilizing the gore® excluder® aaa endoprosthesis.The patient tolerated the procedure.On (b)(6) 2025, it was reported that there is a planned reintervention to repair a possible type 1b endoleak.On (b)(6) 2025, the patient underwent an endovascular procedure utilizing the gore® excluder® aaa endoprosthesis to repair the type 1b endoleak.The patient tolerated the procedure.
Additional Manufacturer Narrative
Added g3/g3, h1/h1, h6.The imaging evaluation determined the following: one time point was available for evaluation: post-implantation cta dated on (b)(6) 2025.The imaging suggested possible contrast outside the implanted devices within the aneurysm sac; however, confirmation cannot be made without a non-contrast axial series.The comparison series submitted for evaluation did not identify lack of distal device apposition in either common iliac artery, nor was contrast outside the distal device limbs.The length from the distal end of the leg in the right common iliac (rci) to the right iliac bifurcation measured approximately 17.4 mm by centerline, with diameters ranging from about 9.6 mm to 12.6 mm; no contrast outside the implanted device limb in the rci was identified.The length from the distal end of the leg in the left common iliac (lci) to the left iliac bifurcation measured approximately 46.0 mm by centerline, with diameters ranging from about 9.8 mm to 13.3 mm; no contrast outside the implanted device limb in the lci was observed.Based on these findings, a distal type i endoleak involving the distal ends of the limbs in the rci or lci cannot be confirmed.

• 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: monique nwanze ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23572691
• Report Number: 3007284313-2025-04372
• Device Sequence Number: 21383871
• Product Code: MIH
• UDI-Device Identifier: 00733132618651
• UDI-Public: (01)00733132618651(17)210226
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 12/09/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/26/2021
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2018
• 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: 79 YR
• Patient Sex: Male