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

Model Number PTB8106275

Device Problem Defective Component (2292)

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

Event Date 09/12/2022

Event Type  malfunction  

Event Description

The sheath that was being used for a tips would not accept the stent.The failed stent never went into the body and the case was not affected.We used a second stent that worked without any problems.Fda safety report id #(b)(4).

• Brand Name: VIATORR
• Type of Device: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): W. L. GORE & ASSOCIATES
• MDR Report Key: 15428470
• MDR Text Key: 300225298
• Report Number: MW5112068
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PTB8106275
• Device Catalogue Number: PTB8106275
• 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: 72 YR
• Patient Sex: Male