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

Catalog Number	CEB231210A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	11/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore: on (b)(6) 2025, the patient underwent endovascular treatment for an abdominal aortic aneurysm using the gore® excluder® conformable aaa endoprosthesis, gore® excluder® aaa endoprosthesis, and the gore® excluder® iliac branch endoprosthesis (ibe).On an unknown date in (b)(6) 2025, the patient was hospitalized to undergo coronary artery bypass grafting (cabg).A computed tomography (ct) scan revealed an occlusion extending from the proximal portion of the contralateral limb of the trunk-ipsilateral leg endoprosthesis to the left common femoral artery.The internal iliac artery was also occluded.On (b)(6) 2025, the patient underwent a reintervention to treat the occlusion.Thrombectomy using fogarty catheters was attempted.Because complete removal of thrombus was not achieved, an additional stent graft was placed as an inner lining.Furthermore, due to vessel angulation near the flow divider of the iliac branch component (ibe), a bare-metal stent was additionally deployed.Blood flow improved but flow distal to the common femoral artery remained reduced.The procedure was concluded with a plan for follow-up observation.No treatment was performed for the occlusion of the left internal iliac artery.Attending physician¿s opinion: the narrowing at the external iliac artery origin (near the flow divider of the ibe) is considered the primary issue.Narrowing of the lumen at the proglide puncture site was also observed, which likely contributed significantly.Pre- and postoperative ct scans showed luminal narrowing distal to the common femoral artery.These multiple factors are presumed to have led to the occlusion.
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.

• 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: ayako yoshioka ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23724110
• Report Number: 3013164176-2025-02801
• Device Sequence Number: 10629000
• Product Code: MIH
• UDI-Device Identifier: 00733132635290
• UDI-Public: (01)00733132635290(17)280708
• 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: 2025
• 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): 12/05/2025

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: CEB231210A
• 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: 11/18/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male