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	Obstruction of Flow (2423)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	05/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the patient underwent an endovascular procedure to treat an aortoiliac aneurysm utilizing gore® excluder® iliac branch endoprosthesis (iliac branch component) and gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) extending into the external iliac artery (reference (b)(4) for the vbx device).At the patient's one month follow-up scan, everything looked ok; however, there appeared to be a narrowing below the vbx device in the external iliac, so the physician elected to put the patient on eliquis out of concern of thrombosis.On (b)(6) 2026, at another follow-up scan, there was thrombosis in the vbx device in the external iliac to the flow divider of the iliac branch component.Reportedly, the interface between the artery and the vbx device looked "kinked"; however, the vbx stent itself looked ok besides the thrombosis, as it did not look narrowed.The physician reported the cause of the thrombosis was the patient's small, calcified arteries and tortuosity; however, the patient's artery sizes were reportedly on label for device size.On (b)(6) 2026, the patient underwent a reintervention procedure where the physician was planning to remove the clot and extend the vbx device.The physician opened up the patient's right common femoral artery for access to see if they could get a wire up the occluded right external iliac artery.The physician attempted this for about five minutes and then elected to do a fem-fem bypass instead using a gore® propaten® vascular graft.It was reported the patient was doing fine at this point.
Additional Manufacturer Narrative
H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.H6: code c20 - the device remains implanted and, therefore, was not available for direct analysis by gore.Gore clinical imaging evaluation: the imaging evaluation performed by a clinical imaging specialist showed the following: one time-point available for evaluation: post-implantation cta dated (b)(6) 2026.The proximal vbx stent extending into the rci/reia appears to be compressed and occluded.The length of the occlusion within stent(s) appears to be ~13cm, by centerline.There is occlusion throughout the implanted stent(s) in the rci and distally in the reia and the native vessel distally to the level of the right femoral head.Contrast is visualized in the right external iliac artery at the level of the right femoral head.The contrast appears to originate from a collateral vessel.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.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: brianna zipprich ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 25443612
• Report Number: 3013164176-2026-03068
• Device Sequence Number: 17574308
• Product Code: MIH
• UDI-Device Identifier: 00733132635290
• UDI-Public: (01)00733132635290(17)280818
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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: 05/26/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2025
• 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: Required Intervention; Hospitalization; Other
• Patient Age: 68 YR
• Patient Sex: Male