BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIFECTA STENTED TISSUE VALVE

    MDR report key: 3954788 · Received July 18, 2014

    Report

    Report Number
    3001883144-2014-00014
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWR
    PMA / PMN Number
    P100029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED TO SJM INDICATED A PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT PROCEDURE IMPLANTING A 19MM TRIFECTA VALVE DUE TO SEVERE AORTIC STENOSIS. A FOLLOW-UP TRANSTHORACIC ECHOCARDIOGRAM REVEALED THE RIGHT CORONARY CUSP OF THE VALVE WAS IMMOBILE, AND THE LEFT CORONARY CUSP AND NON-CORONARY CUSP APPEARED TO BE ADHERED AT THE COMMISSURE. THE PATIENT UNDERWENT A BALLOON AORTIC VALVULOPLASTY ON (B)(6) 2014, BUT THE PATIENT'S CONDITION BECAME WORSE. THE PATIENT UNDERWENT A RE-DO AORTIC VALVE REPLACEMENT AND THE TRIFECTA VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S SMALLER 18MM MECHANICAL VALVE. ALL THREE CUSPS OF THE TRIFECTA VALVE WERE REPORTED TO BE STIFFENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423074 TRIFECTA STENTED TISSUE VALVE STENTED TISSUE VALVE LWR ST. JUDE MEDICAL TF-19A

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R