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

Catalog Number	HGB161007A
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Malposition of Device (2616); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.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 (b)(6) 2026, this patient underwent endovascular treatment for a left internal iliac artery aneurysm using gore® excluder® iliac branch endoprosthesis.After deploying the iliac branch component(ibc) in right iliac artery, the internal iliac component(iic) was advanced using u-turn technique.During advancing the iic device, the dsf sheath became dislodged from the right internal iliac gate.The delivery of the iic device was continued, but it was difficult, and x-ray imaging confirmed that the root of the olive tip had bent 180 degrees.Attempts were made to withdraw the device; however, the removal was difficult.During repeated push-and-pull manipulation of the delivery catheter, the stent graft initiated to deploy within the ipsilateral leg of ibc device and subsequently fully deployed.Upon withdrawing the delivery catheter, it was confirmed that the distal part of the delivery catheter was separated.An attempt was made to retrieve it from the ipsilateral side using a snare catheter but was unsuccessful, so the contralateral side was punctured, and the separated distal part was successfully retrieved with a snare catheter.The procedure then continued using up and over technique and was completed uneventfully.The patient tolerated the procedure.The physician reported that it was recognized that the dsf sheath had come out of the internal iliac gate during advancing the iic device using u-turn technique, but the iic device was still considered deliverable.It was also reported that the catheter might have been pushed too forcefully.

• Brand Name: GORE® EXCLUDER® ILIAC BRANCH 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: hiroko sakamiya ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24385869
• Report Number: 3013164176-2026-02909
• Device Sequence Number: 21402344
• Product Code: MIH
• UDI-Device Identifier: 00733132635313
• UDI-Public: (01)00733132635313(17)280810
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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: HGB161007A
• 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: 02/02/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2025
• 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
• Patient Age: 78 YR
• Patient Sex: Male