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

Catalog Number	PLC161200
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Codes	Insufficient Information (4580); Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	04/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records indicated the lot met pre-release specifications.The device remains implanted, therefore a device evaluation cannot be performed.Gore intends to contact the study site for additional information.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
It was reported to gore that on (b)(6) 2016 this patient underwent an endovascular procedure and was implanted with a gore® excluder® contralateral leg component to treat an abdominal aortic aneurysm.Reportedly, the baseline measurement of the aneurysm diameter performed during computed tomography angiography (cta) imaging was 50 mm.On (b)(6) 2016 follow- up imaging identified a distal type 1 endoleak with an aneurysm sac now measuring 53 mm and the relationship was stated to be unrelated to the device or the procedure.However, between april 6, 2018 and may 31, 2025, yearly follow-up measurements were performed, revealing that the aneurysm had increased from 55 mm to 85 mm.It is currently unknown to gore if a reintervention has been considered by the physician to treat the type 1b endoleak.
Additional Manufacturer Narrative
Emdr section h6: codes have been added/updated to reflect the extent of the investigation performed: h6.Health effect ¿ clinical code: replaced e2401 with e2121.Added e050102.H6.Health effect ¿ impact code: added f0101.Gore also considers selecting f30 to reflect the impact of disease progression on vessel aneurysm increase leading to compromised device seal and therefore insufficient therapeutic effect.Due to temporary program limitations, this code was not selected in the above table.Code f24 selected in the initial report is being upheld as no additional information was received for this code group.H6.Component code: replaced g07003 with g04122.H6.Type of investigation: added b20, b14, b11.Gore also considers selecting code b31 to indicate that instructions for use were reviewed.Due to temporary program limitations, this code was not selected in the above table.H6.Investigation findings: replaced c21 with c19.Code c19: a review of the manufacturing records indicated the lot met pre-release specifications.Code c24 was selected to indicate a device malfunction for inadequate seal in the patient's vasculature presumably due to disease progression enlarging the vessel diameter and leading to the type 1b endoleak.H6.Investigation conclusions: replaced d16 with d15.Added d12.No further information was received for this patient.Based on the incident description and the subsequent investigation, we are unable to determine the cause of this incident and assign a root cause.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: endoleak and aneurysm enlargement.

• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: thomas giebing ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23855551
• Report Number: 3007284313-2025-04469
• Device Sequence Number: 12044322
• Product Code: MIH
• UDI-Device Identifier: 00733132618705
• UDI-Public: (01)00733132618705(17)160930
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2026

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: 09/30/2016
• Device Catalogue Number: PLC161200
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 76 KG