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

Catalog Number	VBCR081501A
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following patient information was asked to the physician but was not available: initials, weight, date of birth, comorbidities, medications.A1: the patient identifier (in confidence) reflect the gore internal case number.No patient specific details have been provided.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 cfr 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
On (b)(6) 2025, a patient had a procedure to treat venous outflow where an 8 mm x 15 cm gore® viabahn® endoprosthesis was intended to be used in an unknown anatomical location.It was reported the physician accessed the patient using an 8f terumo introducer sheath over an.035" glidewire.It is unknown if the target area was pre-dilated.Reportedly, the delivery catheter advanced to the target treatment zone without incidence.During deployment, the deployment line was pulled and broke.Reportedly, 3-4 centimeters of the endoprosthesis remained constrained and on the catheter.The delivery catheter could not be removed with the endoprosthesis still attached.It was reported a balloon was advanced and inflated to high pressure to get the deployment line to rupture and the stent to expand.Another attempt to remove the delivery catheter was made, and it appeared the stent started to buckle.Reportedly, more ballooning was done, and the aggressive ballooning caused the stent to move.A second gore® viabahn® device was used to fully treat the target area.It was reported there was no impact to the patient other than the procedure took longer than normal.
Additional Manufacturer Narrative
H6 adverse event problem codes - updated conclusion codes based on investigation.A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.Product return evaluation: the report of gore® viabahn® endoprosthesis deployment line breakage after partial expansion of the endoprosthesis was confirmed.The deployment knob with attached deployment line segment was returned for evaluation, confirming the reported deployment line breakage.The gore® viabahn® endoprosthesis delivery system was not returned.One angiographic image (non dicom) was provided from the field showing a partially expanded endoprosthesis, consistent with the complaint details as reported.A root cause for the deployment line breakage could not be established based on evaluation of the returned device components nor the single image provided.It was reported that the gore® viabahn® endoprosthesis delivery system could not be separate from the partially expanded endoprosthesis and a balloon was used to force the constrained portion of the endoprosthesis to deploy, resulting in movement of the device from the target location.The cause of the reported inability to withdraw the delivery system is consistent with the partially deployed condition of the device as reported, however the withdrawal difficulty could not be independently confirmed and the root cause could not be established with the information available.

• 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: jorja nackard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22081810
• Report Number: 2017233-2025-06230
• Device Sequence Number: 12499494
• Product Code: PFV
• UDI-Device Identifier: 00733132623549
• UDI-Public: (01)00733132623549(17)271105
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P130006
• 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): 07/30/2025

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
• Device Catalogue Number: VBCR081501A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2024
• 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: 52 YR
• Patient Sex: Male