MAUDE Adverse Event Report: ST. JUDE MEDICAL TRIFECTA; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TF-25A

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 05/22/2014

Event Type  malfunction  

Event Description

Surgeon concerned valve deteriorating early.

• Brand Name: TRIFECTA
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL; 2305 walnut street; roseville MN 55113
• MDR Report Key: 6676629
• MDR Text Key: 78681902
• Report Number: 6676629
• Device Sequence Number: 1
• Product Code: LWR
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/22/2015
• Device Model Number: TF-25A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/07/2017
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 45 YR