MAUDE Adverse Event Report: ST JUDE MEDICAL TRIFECTA AORTIC VALVE

Model Number TF-25A

Device Problem Incomplete Coaptation (2507)

Patient Problem No Code Available (3191)

Event Date 05/27/2014

Event Type  Injury  

Event Description

Pt had an aortic valve replacement and post cardiotomy the implanted valve displayed "restricted leaflet didn't open and close" according to surgeon.The pt was placed back on cardiopulmonary bypass and newly implanted valve was replaced with a different one.

• Brand Name: TRIFECTA AORTIC VALVE
• Type of Device: AORTIC VALVE
• Manufacturer (Section D): ST JUDE MEDICAL; 177 county rd b east; st paul MN 55117
• MDR Report Key: 3874084
• MDR Text Key: 4509807
• Report Number: MW5036575
• 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: 05/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2016
• Device Model Number: TF-25A
• Device Catalogue Number: TF-25A
• Device Lot Number: 14423007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 107