MAUDE Adverse Event Report: ST. JUDE MEDICAL TRIFECTA MECHANICAL AORTIC VALVE; HEART-VALVE, MECHANICAL

Model Number 25 MM

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2016

Event Type  malfunction  

Event Description

The valve was implanted and was defective and the physician had to explant the valve after coming off bypass machine and go back on bypass to implant another valve.The mechanical valve was implanted and was defective; the physician had to explant the valve after the patient had come off the bypass machine.The patient had to be placed back on bypass to implant another valve, a tissue valve.The patient did well and has been discharged home.

• Brand Name: TRIFECTA MECHANICAL AORTIC VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL; 177 county road b e; saint paul MN 55117
• MDR Report Key: 6102144
• MDR Text Key: 59887395
• Report Number: 6102144
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 25 MM
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/02/2016
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CARDIAC DRUGS; OTHER, AS LISTED ABOVE; THE PATIENT WAS INTUBATED AND SEDATED ON HEART AND
• Patient Age: 79 YR