MAUDE Adverse Event Report: ST. JUDE MEDICAL ST JUDE MEDICAL; TRIFECTA VALVE AORTIC 25MM

Model Number TF-25A

Device Problem Improper Flow or Infusion (2954)

Patient Problem Aortic Regurgitation (1716)

Event Date 05/25/2016

Event Type  Injury  

Event Description

Cv surgeon implanted aortic value.Mild to moderate central regurgitation was seen through the bioprosthetic valve.Tee revealed a leaflet value on device was not closing.It did not seem to coapt well, no other abnormalities.Aortic value explanted and a new device re-implanted.Repeat tee preformed with no aortic insufficiency.To recovery in stable condition.

• Brand Name: ST JUDE MEDICAL
• Type of Device: TRIFECTA VALVE AORTIC 25MM
• Manufacturer (Section D): ST. JUDE MEDICAL; 1504 nw 135th st ; smithville MO 64083
• MDR Report Key: 5694313
• MDR Text Key: 46477349
• Report Number: MW5062590
• Device Sequence Number: 1
• Product Code: LWR
• 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: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/11/2017
• Device Model Number: TF-25A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/26/2016
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 84