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

Catalog Number	PLC141000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, this patient underwent planned endovascular treatment of an abdominal aortic aneurysm (aaa) and was implanted with gore® excluder® conformable aaa endoprosthesis devices.Pre-procedure computed tomography angiography (cta) performed on (b)(6) 2025, determined the maximum diameter of the abdominal aorta measured 63mm with a maximum diameter proximal landing zone of 23mm.Successful access, delivery, and accurate deployment of the devices to their intended location, and retrieval of the delivery system was reported.There were no corrective procedure(s) or complications related to the device, procedure, or withdrawal of the delivery system.The patient tolerated the procedure and was discharged to home (self-care) on (b)(6) 2025.On (b)(6) 2025, the patient underwent follow-up computed tomography angiography (cta).Review by gore imaging services (gis) reports a type ii endoleak originating from five lumbar arteries (lumbar dominant), the ima is not patent.Gis additionally reports gore device compression/infolding.Review of the cta by the site reports a type ii endoleak, the maximum diameter of the abdominal aorta is reported to measure 58mm and reports/confirms compression of the right iliac limb (plc141000/30638662) in the aorta.The site additionally reports all devices are reported to be patent, with no additional device integrity issues.There are no scheduled procedures planned for the patient at this time; the event is ongoing.
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.

• 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23795273
• Report Number: 3013164176-2025-02816
• Device Sequence Number: 18759481
• Product Code: MIH
• UDI-Device Identifier: 00733132618637
• UDI-Public: (01)00733132618637(17)280611
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Study,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PLC141000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/12/2025
• Date Device Manufactured: 06/13/2025
• 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
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 82 KG