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

Model Number	VBHR070502A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Scrub tech flushed stent and saw that it was leaking around seal that is used to deploy stent.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, ARTERIOVENOUS (AV) DIALYSIS ACCESS CIRCUIT STENOSIS
• Manufacturer (Section D): W. L. GORE ASSOCIATES, INC.; 1505 north fourth street; flagstaff AZ 86004
• MDR Report Key: 20673652
• Report Number: 20673652
• Device Sequence Number: 20931472
• Product Code: PFV
• UDI-Device Identifier: 00733132622948
• UDI-Public: (01)00733132622948(17)260812
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2024
• Report Date (Section F): 10/11/2024

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 Model Number: VBHR070502A
• Device Catalogue Number: VBHR070502A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Date Report Sent to FDA: 10/11/2024