BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRIFECTA STENTED TISSUE VALVE

    MDR report key: 3931255 · Received June 20, 2014

    Report

    Report Number
    3008452825-2014-00022
    Event Type
    Death
    Date Received
    June 20, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 22, 2014
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWR
    PMA / PMN Number
    P100029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THIS INVESTIGATION INDICATED THE VALVE MET SJM SPECIFICATIONS AS SUPPORTED BY THE VALVE'S DEVICE HISTORY RECORD AND THE ANALYSIS PERFORMED. HYDRODYNAMIC TESTING AT THE TIME OF MFG AND UPON RETURN TO ST. JUDE MEDICAL INDICATED THE VALVE FUNCTIONED NORMALLY. THIS TEST ENSURES PROPER CUSPAL COAPTATION AND HEMODYNAMIC PERFORMANCE. THERE WAS NO EVIDENCE TO SUGGEST THAT THERE WAS AN INTRINSIC DEFECT IN THE VALVE. THE CAUSE OF THE REPORTED CUSPS NOT COAPTING PROPERLY RESULTING IN LEAKAGE REMAINS UNK.

    Description of Event or Problem · 1

    A PT UNDERWENT A DOUBLE VALVE REPLACEMENT PROCEDURE AND THE AORTIC VALVE WAS REPLACED WITH THIS 19MM SJM TRIFECTA VALVE. THE PT WAS TAKEN OFF OF BYPASS WITHOUT DIFFICULTY. AN INTRAOPERATIVE ECHOCARDIOGRAM WAS PERFORMED WHICH REVEALED AORTIC REGURGITATION AND THE PT WAS PLACED BACK ON BYPASS. THE VALVE WAS REMOVED AND UPON EXAMINATION OF THE EXPLANTED VALVE, IT WAS REPORTED THAT THE CUSPS WERE NOT COAPTING PROPERLY. AN SJM 19MM REGENT MECHANICAL VALVE WAS IMPLANTED. THERE WAS DIFFICULTY REMOVING THE PT FROM BYPASS. THIS WAS DETERMINED TO BE DUE TO AN EMBOLIZED PLEDGET IN THE MAIN CORONARY ARTERY. THE PLEDGET WAS REMOVED AND THE PT WAS REMOVED FROM BYPASS. DURING THE POSTOPERATIVE PERIOD, THE PT BEGAN TO HEMORRHAGE AND WAS TAKEN BACK TO SURGERY FOR AN EXPLORATION. THE PT WAS FOUND TO HAVE BLEEDING AS A RESULT OF AN ATRIOVENTRICULAR GROOVE RUPTURE. THE RUPTURE COULD NOT BE REPAIRED AND THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364274 TRIFECTA STENTED TISSUE VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL TF-19A

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death| H| R