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

Catalog Number	RLT231414
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Codes	Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	04/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to gore that on (b)(6) 2016, this patient underwent an endovascular procedure and was implanted with gore® excluder® aaa endoprosthesis devices to treat an abdominal aortic aneurysm measuring 55 mm in diameter.On (b)(6) 2021, a type ii endoleak with sac enlargement was diagnosed.Measuring 66 mm compared to 48 mm on (b)(6) 2020.On (b)(6) 2021 coil embolization was performed.It also was reported that on (b)(6) 2025, the patient had discontinued the study as he had expired.
Additional Manufacturer Narrative
The patient referenced in this event file is enrolled in a post market prospective observational cohort registry designed to obtain data on device performance and clinical outcomes of patients treated with gore endovascular aortic products through the global registry for endovascular aortic treatment (great).Medidata rave® is the clinical study database (csd), capturing the data through the grt 10-11 module.The above information was obtained from the csd.A review of the manufacturing records indicated the lot met pre-release specifications.The device remains implanted.Therefore, an evaluation on the device cannot be performed.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.
Additional Manufacturer Narrative
H6, type of investigation: code b11 & b14 added.Investigation findings: code c20 added.Code c21 is no longer applicable.Investigation conclusions: code d1001 & d12 added.Code d16 is no longer applicable.A review of the manufacturing records indicated the lot met pre-release specifications.The device remains implanted and therefore no product evaluation has been performed.The available information reported in the complaint does not reasonably suggest a potential malfunction or product packaging and/or labeling issue has occurred.Per 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: aneurysm enlargement, endoleak.
Additional Manufacturer Narrative
Updated g3.Updated b5: describe event or problem.H6, component code: added code g04122.Code g07003 no longer appliable.Health effect - clinical code: added code e050102.Contacted the study site contact for further information.The reason why patient expired remains unknown.
Event or Problem Description
It was reported to gore that on (b)(6) 2016, this patient underwent an endovascular procedure and was implanted with gore® excluder® aaa endoprosthesis devices to treat an abdominal aortic aneurysm measuring 55 mm in diameter.On (b)(6) 2021, a type ii endoleak with sac enlargement was diagnosed measuring 66 mm compared to 48 mm on (b)(6) 2020.On (b)(6) 2021 coil embolization was performed.It also was reported that on (b)(6) 2025, the patient had discontinued the study as he had expired.The patient expired due to unknown reason and unrelated to the device or the procedure.Gore requested information without additional information by the study contact.

• 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: 22529223
• Report Number: 3007284313-2025-04116
• Device Sequence Number: 20685346
• Product Code: MIH
• UDI-Device Identifier: 00733132622375
• UDI-Public: (01)00733132622375(17)181130
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2025

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: 11/30/2018
• Device Catalogue Number: RLT231414
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: 09/05/2025; 09/15/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 09/09/2025; 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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: Required Intervention; Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 170 KG