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

Catalog Number	VBCR131002A
Medical Device Problem Codes	Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, the patient underwent treatment for stenosis in the cephalic arch/subclavian vein where a gore® viabahn® endoprosthesis (viabahn device) was intended to be used.Access to the target site was successfully achieved via a 10fr boston scientific super sheath and a 180 cm boston scientific bentson guidewire without any resistance.Upon delivery of the viabahn device, deployment was initiated by pulling on the deployment line.During this process, the physician encountered resistance.The endoprosthesis partially expanded at the distal end; however, expansion ceased midway and could not be completed.Multiple attempts were made to fully deploy the device, but resistance along the deployment line persisted.Ultimately, the device was retrieved in tandem with the sheath and was successfully removed from the patient.The procedure was then completed using balloon angioplasty.It was reported there was no impact to the patient.No tortuous anatomy nor calcification was present in the target treatment area.However, a previously placed stent (manufacturer unknown) was present at the treatment site.The physician is unsure what caused the deployment line to become stuck since they deployed the same way as usual.
Additional Manufacturer Narrative
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
Section h6 updated to reflect completion of investigation.H6 code d19: manufacturing records were reviewed, and the device met all pre-release specifications.H6 code d16 was removed and d15 was added: the viabahn device was returned to gore for evaluation.Evaluation of the returned product indicates the condition of the device as returned was consistent with the primary reported complaint of a stuck viabahn device deployment line after partial expansion.The endoprosthesis as returned for evaluation was expanded at the distal end while remaining partially constrained on the delivery system.Deployment line breakage and endoprosthesis damage consistent with withdrawal of a partially expanded endoprosthesis were noted.The reported deployment failure was not replicated during evaluation.Deployment of the returned device was able to proceed when pulling the broken deployment line at the endoprosthesis, demonstrating that the deployment mechanism itself was not stuck.The root cause of the stuck viabahn device deployment line after partial expansion could not be established.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.

• 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: vanessa rodriguez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22592942
• Report Number: 2017233-2025-06447
• Device Sequence Number: 9005233
• Product Code: PFV
• UDI-Device Identifier: 00733132645923
• UDI-Public: (01)00733132645923(17)280113
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P130006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/05/2025

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: VBCR131002A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2025
• 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 Age: 37 YR
• Patient Sex: Male
• Patient Weight: 77 KG