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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 cfr 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) 2025, this patient underwent endovascular treatment for a ruptured left common iliac artery aneurysm (lciaa) and was implanted with gore® excluder® iliac branch endoprosthesis devices, a gore® excluder® aaa endoprosthesis device and a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) within the left internal ilac artery (liia).An adjunctive procedure was also performed, wherein the internal iliac artery was coil embolized.Pre-procedure computed tomography angiography (cta) performed on (b)(6) 2025, determined the maximum diameter of the abdominal aorta measured 27 mm with a maximum diameter proximal landing zone of 22 mm.The maximum diameter of the right common iliac artery measured 37 mm and the maximum diameter of the left common iliac artery measured 25 mm.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, an intervention was performed due to a type iiib endoleak associated with the gore® excluder® aaa internal iliac branch component (hgb) and the vbx device inplanted within the left internal iliac artery (liia).An additional vbx device was implantedto reline and exclude the endoleak.The patient tolerated the procedure.

• 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23751560
• Report Number: 3013164176-2025-02807
• Device Sequence Number: 5904641
• Product Code: MIH
• UDI-Device Identifier: 00733132635313
• UDI-Public: (01)00733132635313(17)280128
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2025

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 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: 11/19/2025
• Initial Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2025
• 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; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 118 KG