MAUDE Adverse Event Report: ST. JUDE MEDICAL TRIFECTA STENTED TISSUE VALVE

Model Number TF-21A

Device Problem Entrapment of Device (1212)

Patient Problem Aneurysm (1708)

Event Date 01/30/2014

Event Type  Injury  

Event Description

Approximately 18 months post-implant, the pt experience a second aortic aneurysm and underwent a re-do ascending aorta replacement during the procedure stenosis was observed on the sjm valve and the cusps were adhered at the commissure.A re-do aortic valve replacement was considered, but not performed as the adhered cusps were able to be separated.The pt recovered and was discharged.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis and remains implanted.A review of the device history record was not possible since the serial number was unavailable.Based on the information received, the cause of the reported stenosis could not be conclusively determined.

• Brand Name: TRIFECTA STENTED TISSUE VALVE
• Type of Device: STENTED TISSUE VALVE
• Manufacturer (Section D): ST. JUDE MEDICAL; alajuela ; CS
• Manufacturer Contact: denise johnson, rn ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 3949167
• MDR Text Key: 4601547
• Report Number: 3008452825-2014-00024
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TF-21A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR