BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRIFECTA STENTED TISSUE VALVE

    MDR report key: 3910056 · Received June 13, 2014

    Report

    Report Number
    3007113487-2014-00009
    Event Type
    Death
    Date Received
    June 13, 2014
    Report Date
    June 3, 2014
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWR
    PMA / PMN Number
    P100029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT DIED IN (B)(6) 2013 DUE TO ACUTE HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350534 TRIFECTA STENTED TISSUE VALVE STENTED TISSUE VALVE LWR ST. JUDE MEDICAL TF-23A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death