MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA (CS) TRIFECTA VALVE,21MM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TF-21A

Device Problems Structural Problem (2506); Incomplete Coaptation (2507)

Patient Problems Regurgitation (2259); Prolapse (2475)

Event Date 07/22/2014

Event Type  Injury  

Event Description

The information provided to sjm indicated this 21mm sjm trifecta valve was implanted in a female patient following use of an sjm sizer set (tf 2000).Single non-pledgeted sutures were used.The patient also underwent mitral valve replacement and coronary artery bypass during the same procedure.Post-procedure, echocardiography revealed regurgitation and poor coaptation due to a prolapsed/folded leaflet at the level of the right coronary sinus.The valve was explanted and replaced by another manufacturer's smaller19mm biological valve.The patient was stable following the procedure.

Manufacturer Narrative

Additional information: product analysis: the results of this investigation concluded the presence of a thin layer of fibrin on all cusps and thin, patchy organizing thrombus on the sewing cuff.Special stains were negative for organisms, and no acute inflammation or significant calcifications were present.There was no evidence found to suggest the cause of the fibrin and thrombus formation was due to an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.The cause of the fibrin and thrombus formation remains unknown.

• Brand Name: TRIFECTA VALVE,21MM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (CS); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897 -405; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA (CS); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897 -405; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 3994752
• MDR Text Key: 4823765
• Report Number: 3008452825-2014-00032
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PP100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 11/19/2015
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 4380327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR