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

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2023

Event Type  malfunction  

Event Description

Viatorr did not deploy removed and used a new stent.No patient harm.

• Brand Name: VIATORR STENT
• Type of Device: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.
• MDR Report Key: 16513019
• MDR Text Key: 311043769
• Report Number: MW5115583
• Device Sequence Number: 1
• Product Code: MIR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male