MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIATORR TIPS ENDOPROSTHESIS; SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS

Model Number	PTB8106275
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Physician tried to advance stent into sheath, it would not advance properly.He pulled back and noted ripped stent / strut sticking out of the stent.

• Brand Name: GORE VIATORR TIPS ENDOPROSTHESIS
• Common Device Name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 north fourth street; flagstaff AZ 86004
• MDR Report Key: 22563991
• Report Number: 22563991
• Device Sequence Number: 9247598
• Product Code: MIR
• UDI-Device Identifier: 00733132635023
• UDI-Public: (01)00733132635023
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/18/2025
• Report Date (Section F): 07/18/2025

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 Model Number: PTB8106275
• Device Catalogue Number: PTB8106275
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 07/22/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2025
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Date Report Sent to FDA: 07/18/2025