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

Catalog Number	CEB231410A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	04/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.As gore was unable to determine which device/device component is involved in this reportable adverse event, the following additional device will be identified in this report: catalog #hgb161207a, serial # (b)(6), udi(b)(4) catalog #hgb161407a, serial # (b)(6), udi(b)(4).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 have not 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
The following was reported to gore: on (b)(6) 2026, the patient underwent endovascular treatment of an abdominal aortic aneurysm and an iliac artery aneurysm using gore® excluder® aaa endoprosthesis devices (a trunk ipsilateral leg endoprosthesis, an aortic extender endoprosthesis, and two contralateral leg endoprosthesis devices) and gore® excluder® iliac branch endoprosthesis devices (an iliac branch component and two internal iliac component devices).The gore® excluder® aaa endoprosthesis devices and the gore® excluder® iliac branch endoprosthesis devices were implanted using gore® dryseal flex introducer sheath devices and a gore® molding & occlusion balloon catheter.It was noted that the aortic extender endoprosthesis was implanted to cover the lumbar artery and the inferior mesenteric artery before the trunk ipsilateral leg endoprosthesis was deployed.The patient tolerated the procedure.After the procedure, the patient complained of a headache.And the patient fell while walking and hit his head.Three days after the procedure, mri confirmed a cerebral infarction.The fall appears to have been related to visual field constriction secondary to the cerebral infarction.It is unknown whether any treatment was provided for the cerebral infarction.The physician reported that the wire and catheter manipulation was intended to be kept within the descending aorta; however, the wire may have advanced into the aortic arch due to tension during device insertion and related maneuvers.

• 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: asami aizawa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 25121116
• Report Number: 3013164176-2026-03012
• Device Sequence Number: 10694701
• Product Code: MIH
• UDI-Device Identifier: 00733132635306
• UDI-Public: (01)00733132635306(17)281213
• 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): 05/08/2026

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: CEB231410A
• 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: 04/20/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Male