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

Model Number 29MM

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2015

Event Type  Injury  

Event Description

Aortic insufficiency within prosthesis and not paravalvular.Valve replaced extending operating room time.Surgeon believes there was a manufacturing defect.Valve released to rep.

• Brand Name: ST. JUDE
• Type of Device: TRIFECTA AORTIC VALVE
• Manufacturer (Section D): ST. JUDE MEDICAL; st. paul MN 55117
• MDR Report Key: 4895144
• MDR Text Key: 6022515
• Report Number: MW5043579
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2016
• Device Model Number: 29MM
• Device Lot Number: TF-29A
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR