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

Catalog Number	PLC121000
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Codes	Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	11/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: code c21 - results pending determination and completion of investigations.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.As it is unknown which device is directly implicated in this endoleak event, the following devices will also be included in this report: catalog #pll161207 / serial #(b)(6) / udi # (b)(4) catalog #pll161407 / serial #(b)(6) / udi #(b)(4).
Event or Problem Description
On (b)(6) 2021, the patient underwent an endovascular procedure to treat an abdominal aortic aneurysm (aaa) utilizing gore® excluder® aaa endoprosthesis devices (rlt261412, pll161407, pll161207, and plc121000).On an unknown date in (b)(6) 2025, a type 1b endoleak was observed in the patient's left iliac artery through imaging and a reintervention was planned.It is unknown whether the endoleak was associated with the pll161407, pll161207, or plc121000.The cause of the endoleak is unknown.The endoleak led to aneurysm enlargement; however, growth amount is unknown.On (b)(6) 2026, the patient underwent a reintervention procedure to treat the type 1b endoleak utilizing a pll161007.The patient's left hypogastric artery was embolized.The endoleak was resolved.The patient tolerated the procedure.
Additional Manufacturer Narrative
Added g3/g4, h1/h2, h6.Additional information: removed b21 type of investigation not yet determined and added b14 analysis of production records, b13 communication/interviews, and b20 device not accessible for testing.Removed c21 results pending completion of investigation and added c19 no device problem found and c20 no findings available.Removed d16 conclusion not yet available and added d15 cause not established and d12 known inherent risk of device.H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.H6: code c20 - the device remains implanted and, therefore, was not available for direct analysis by gore.

• 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: brianna zipprich ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23994742
• Report Number: 3013164176-2026-02865
• Device Sequence Number: 18741555
• Product Code: MIH
• UDI-Device Identifier: 00733132618613
• UDI-Public: (01)00733132618613(17)220328
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 01/12/2026

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: 03/28/2022
• Device Catalogue Number: PLC121000
• 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: 11/01/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2019
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 71 KG