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

Catalog Number	RLT311413
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	05/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1, patient identifier (in confidence): currently unknown.Until further notice, data provided in this field recflect gore's internal reference number for this case.A review of the manufacturing records indicated the lot met all pre-release specifications.The device remains implanted.Therefore, an evaluation of the device cannot be performed.Gore has contacted the source for additional information on this medical device incident.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
On an unknown date in (b)(6) 2018, this patient underwent an endovascular procedure and was implanted with gore® excluder® aaa endoprosthesis devices to treat an abdominal aortic aneurysm.During follow-up imaging presumably in (b)(6) 2025, a type 1a endoleak of the gore® excluder® trunk-ipsilateral leg component was diagnosed.On (b)(6) 2025, the endoleak was solved during a reintervention with an additional gore® excluder® conformable aaa aortic extender endoprosthesis.
Additional Manufacturer Narrative
H6, investigation conclusions: replaced code d1501 with d15.Updated g1.
Additional Manufacturer Narrative
Emdr section h6: codes have been added/updated to reflect the extent of the investigation performed.H6, health effect ¿ impact code: added code f2301.H6, component code: replaced code g07003 with g04122.H6, type of investigation: added codes b20, b14, b11.H6, investigation findings: replaced code c21 with c24.H6, investigation conclusions: replaced code d16 with d15.Added code d12.As part of our routine quality procedures, each batch of devices undergoes comprehensive quality control testing and inspections prior to release for distribution.Gore reviewed the manufacturing records associated with the reported lot number and verified that all release criteria had been met.Neither clinical images enabling direct assessment of product performance nor the product itself (remains implanted) was returned for evaluation.Based on the incident description and the subsequent investigation, no further information was provided to gore, we are unable to determine the cause of this incident and assign a root cause.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: endoleak.

• 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: ena haskovic aran ; 1505 n. fourth street; flagstaff, AZ ; GM ; 9285263030
• MDR Report Key: 22335623
• Report Number: 3007284313-2025-04056
• Device Sequence Number: 9126604
• Product Code: MIH
• UDI-Device Identifier: 00733132619078
• UDI-Public: (01)00733132619078(17)201211
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2025

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: 12/11/2020
• Device Catalogue Number: RLT311413
• 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: 05/29/2025
• Supplement Date Received by Manufacturer: 09/24/2025; Not provided
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 09/25/2025; 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2017
• 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
• Patient Sex: Unknown