MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL

Catalog Number	BXBL087902A
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	12/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, this patient underwent endovascular treatment of the infrarenal aorta for aortoiliac occlusive disease (aiod) and was implanted with an aortic device and two gore® viabahn® vbx balloon expandable endoprosthesis devices.The patient tolerated the procedure.It was reported that approximately 1 hour post implant the patient began to exhibit symptoms and the physician determined all three devices were occluded.The patient underwent a thrombectomy and it was determined that the patient had developed rhabdomyolysis.The patient tolerated the procedure however it is believed that the patient may require amputation.
Additional Manufacturer Narrative
The manufacturing records were reviewed and documented in the product history task.The device lot met all pre-release specifications.Neither clinical images enabling direct assessment of product performance nor the product itself were returned for evaluation cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.The gore® viabahn® vbx balloon expandable endoprosthesis instruction for use (ifu), section hazards and adverse events states, complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: thrombosis or occlusion.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.
Additional Manufacturer Narrative
H6 adverse event problem codes: removed d12 known inherent risk of device investigation conclusion code.Additionally, the below ifu statement no longer pertains: the gore® viabahn® vbx balloon expandable endoprosthesis instruction for use (ifu), section hazards and adverse events states, complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: thrombosis or occlusion.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: jorja nackard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23818287
• Report Number: 2017233-2025-06949
• Device Sequence Number: 9299767
• Product Code: PRL
• UDI-Device Identifier: 00733132658534
• UDI-Public: (01)00733132658534(17)280410
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• 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,Followup
• Report Date (Section B): 01/13/2026

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: BXBL087902A
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2025
• 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
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 82 KG