BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIFECTA VALVE

    MDR report key: 2970947 · Received February 15, 2013

    Report

    Report Number
    3007113487-2013-00004
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC. (CS-WOODRIDGE)
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE VALVE WAS EXPLANTED DUE TO LEAKAGE AND REPLACED BY ANOTHER MFR'S DEVICE. ONE LEAFLET WAS NOTED TO BE PARTIALLY DETACHED FROM THE STRUT AT EXPLANT. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69665 TRIFECTA VALVE NONE LWR ST. JUDE MEDICAL, INC. (CS-WOODRIDGE) TF-23A

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R