MAUDE Adverse Event Report: ST. JUDE MEDICAL TRIFECTA; VALVE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 05/12/2017

Event Type  Injury  

Event Description

Trifecta valve in aortic position.Early valve failure due to leaflet fusion.We have seen multiple trifecta valve failure this year leading to add'l procedures and surgeries.

• Brand Name: TRIFECTA
• Type of Device: VALVE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 6597637
• MDR Text Key: 76308413
• Report Number: MW5070057
• Device Sequence Number: 1
• Product Code: LWQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 20 YR
• Patient Weight: 58