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	VBJR081502A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction

• 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 ; 1505 n. fourth street; flagstaff, AZ 86004 ; +1(928)526-3030
• MDR Report Key: 50925884
• Report Number: 2017233-2026-08095
• Device Sequence Number: 20175757
• Product Code: PFV
• UDI-Device Identifier: 00733132623839
• UDI-Public: (01)00733132623839(17)280109
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: VBJR081502A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2025
• 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