MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, ARTERIOVENOUS (AV) DIALYSIS ACCESS CIRCUIT STENOSIS

Catalog Number	VBCR070502A
Medical Device Problem Codes	Entrapment of Device (1212); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6 - code c19: review of device manufacturing record history confirmed device met pre-release specifications.H6 - code b20: the device remains in the patient and was therefore, not available for analysis.H6 - code b15: images were provided and included in the engineering evaluation.Engineering evaluation state: the viabahn® device reportedly deployed at site but failed to fully expand at the target lesion, as evidenced by stent end 'bunching'.As reported, no pre-dilation was performed prior to device introduction and deployment.An imaging evaluation of items returned for review confirmed stenosis or 'bunching' at the end of an implanted viabahn® device.Vessel stenosis was visualized consistent with reported information indicating a section of stenotic lesion was not covered.The ifu instructs the user to perform percutaneous transluminal angioplasty (pta) if treating stenotic or occlusive lesions prior to device introduction.Additionally, the viabahn® device is contraindicated for non-compliant lesions where full expansion of an angioplasty balloon catheter was not achieved during pre-dilatation.Therefore, the root cause of the reported stent end 'bunching' is consistent with use error, specifically user does not perform pta.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.
Event or Problem Description
The following was reported to gore: a patient presented for treatment of an in-stent edge stenosis in the patient's arm.As reported, there was a pre-existing gore® viabahn® endoprosthesis (viabahn® device).Implant date of pre-existing viabahn® stent is unknown.During an a-v circuit intervention, the target lesion was not pre-dilated.A 7mm x 5cm viabahn® device was deployed.On imaging, the expanded viabahn® stent end appeared to be bunched.The viabahn® stent was post-dilated, which further improved the blood flow.As reported, a small section of the stenotic lesion was not covered, and the compressed area was still present at the end of the procedure.The physician chose a 'wait and see' approach.The patient tolerated the procedure and was reported to be recovering well.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, ARTERIOVENOUS (AV) DIALYSIS ACCESS CIRCUIT STENOSIS
• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24780103
• Report Number: 2017233-2026-07342
• Device Sequence Number: 20366633
• Product Code: PFV
• UDI-Device Identifier: 00733132623440
• UDI-Public: (01)00733132623440(17)280601
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130006
• 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): 04/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VBCR070502A
• 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: 03/19/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2025
• 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
• Patient Sex: Unknown