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

Catalog Number	BXB075902A
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Codes	Pain (1994); Thrombosis/Thrombus (4440)
Date of Event	06/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, a patient underwent a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) procedure.Two gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) devices, measuring 7 mm x 59 mm, were implanted in the left renal artery.Following the index procedure, the patient reportedly left the hospital against medical advice (ama) and did not take prescribed plavix (clopidogrel).On (b)(6) 2024, the patient returned with pain and underwent a reintervention procedure.During the procedure, a clot was identified within a left renal artery vbx device.According to the physician, the thrombotic event was believed to be associated with the patient's failure to take prescribed plavix therapy.It was no stenosis present.The affected left renal artery vbx device was relined with additional vbx device(s).The procedure was reportedly well tolerated, and the reporter indicated the intervention was successful.The left renal artery was reported as patent following treatment, and no known residual adverse outcomes were reported at the time of the complaint.
Additional Manufacturer Narrative
A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.The device remains implanted and, therefore, was not available for direct analysis by gore.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.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® 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: 25830533
• Report Number: 2017233-2026-07785
• Device Sequence Number: 10383340
• Product Code: PRL
• UDI-Device Identifier: 00733132658664
• UDI-Public: (01)00733132658664(17)290320
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2026

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: BXB075902A
• 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: 06/24/2026
• Initial Report FDA Received Date: 07/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2026
• 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: Other; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White