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

Catalog Number	VBHR081501A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to gore: on (b)(6) 2026, the physician performed a declot in the patient's left brachial vein.It was reported there were no pre-existing devices in the area of treatment.A cut down was performed and thrombectomy with a fogarty balloon was done.Then a percutaneous transluminal angioplasty (pta) was performed using an 8 x 40 conquest balloon.It was reported there was residual stenosis.Prior to implant of a device, the entire area was pre-dilated with an 8 mm balloon and no resistance was felt while delivering the gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn® device).For the remaining stenosis, an 8mm x 15cm viabahn® device was to be implanted.As there was a cut-down, it was reported a sheath was not used.The viabahn® device was advanced over an.035 stiff angled glide wire.When the deployment line was pulled, a short segment of the line unraveled, but got stuck and further deployment was not possible.Under x-ray, it was confirmed the deployment line was not hung up on anything and there was no device expansion.The constrained viabahn® device was removed.A new viabahn® device was delivered over the same.035 stiff angled glide and the viabahn® device deployed with no issues.The patient did not experience any adverse consequences.
Additional Manufacturer Narrative
Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.H6 - code c19: review of device manufacturing record history confirmed device met pre-release specifications.H6 - code b01: specimen was returned.Results pending completion of investigation.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
The engineering evaluation report details observations made directly on the returned device in addition to device photos captured during evaluation.The returned device evaluation indicates knob detached from the hub, as indicated with loose deployment line and exiting additional line from the transition area of the catheter.Observed also was a partially deployed outer zipper.The reported failure mode of deployment line stuck is not consistent with the findings as deployment could be continued from the knob.Engineering evaluation of the device could not confirm the reported failure to deploy.Replication of this failure mode is not always possible because of differences between conditions seen in vivo (i.E., patient anatomy, procedural conditions) and those seen in the laboratory.The root cause of the reported failure mode could not be established within the engineering evaluation.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• 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: 24236009
• Report Number: 2017233-2026-07103
• Device Sequence Number: 16036866
• Product Code: PFV
• UDI-Device Identifier: 00733132623143
• UDI-Public: (01)00733132623143(17)280813
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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: VBHR081501A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2025
• 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: 55 YR
• Patient Sex: Male