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	Malposition of Device (2616)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	08/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore: on (b)(6), 2026, the patient underwent an endovascular treatment for an abdominal aortic aneurysm and a common iliac artery aneurysm using gore® excluder® conformable aaa endoprosthesis and gore® excluder®aaa endoprosthesis devices.The gore® excluder® iliac branch endoprosthesis (ibe) was planned for implantation in the right iliac artery.The trunk¿ipsilateral leg component was first deployed below the renal arteries, followed by placement of the contralateral leg on the right side and the ipsilateral leg on the left side.A pull-through wire access was then established from the right side, and the iliac branch component was deployed in the right iliac artery using the up-and-over technique.During deployment, the bifurcation between the right internal and external iliac arteries was misidentified, resulting in the contralateral gate of the iliac branch component being inadvertently deployed into the right external iliac artery.Even though cannulation of the right internal iliac artery was attempted, the guidewire could not be adequately straightened to achieve access.Consequently, preservation of the right internal iliac artery was abandoned.The right internal iliac artery was coil embolized, and a stent graft was extended from the right common iliac artery to the right external iliac artery.Following balloon molding of the implanted devices, the procedure was completed.The physician commented that the bifurcation between the internal and external iliac arteries had been misidentified.
Additional Manufacturer Narrative
H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.Ifu statements h6: code d1102: ifu statements the gore® excluder® iliac branch endoprosthesis instructions for use (ifu) were reviewed with respect to the complaint detail for the applicable region and time period, and the following ifu statements were identified in relation to the complaint."[iliac branched component positioning and deployment]" 5.Magnify and center the fluoroscope to the level of the common iliac artery.Reposition and rotate the iliac branch component delivery catheter as necessary to properly position the device in the correct orientation in regard to the anatomy.The long radiopaque marker should be oriented toward the internal iliac artery and the internal iliac leg radiopaque ring should be proximal to the origin of the internal iliac artery in order to obtain internal iliac access.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: rie kaba ; 1505 n. fourth street; flagstaff, AZ 86004 ; +1(928)526-3030
• MDR Report Key: 50423772
• Report Number: 3013164176-2026-03192
• Device Sequence Number: 9634573
• Product Code: MIH
• UDI-Device Identifier: 00733132635290
• UDI-Public: (01)00733132635290(17)290506
• 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): 08/25/2026

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: 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: 08/10/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2026
• 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: 86 YR
• Patient Sex: Male