BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM TRIFECTA STENTED TISSUE VALVE

    MDR report key: 3240465 · Received July 18, 2013

    Report

    Report Number
    8020430-2013-00006
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ST. JUDE MEDICAL CANADA, INC.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY SIX YEARS POSTOPERATIVELY, THE PATIENT WAS SYMPTOMATIC AND RETURNED FOR AN ECHOCARDIOGRAM. THE VALVE WAS EXPLANTED DUE TO PANNUS, THROMBUS, LEAKAGE, AND A TEAR ON THE TOP OF TWO COMMISSURES. IT WAS REPORTED THE SUTURE TAILS WERE OBSERVED TO BE VERY LONG. THE VALVE WAS REPLACED WITH A VALVE FROM ANOTHER MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336366 SJM TRIFECTA STENTED TISSUE VALVE NONE LWR ST. JUDE MEDICAL CANADA, INC. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R