BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIFECTA STENTED TISSUE VALVE

    MDR report key: 3113708 · Received May 10, 2013

    Report

    Report Number
    3001883144-2013-00004
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ST. JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE VALVE WAS EXPLANTED DUE TO ENDOCARDITIS. INTRAOPERATIVELY, PARAVALVULAR VEGETATION AND LEAKAGE WERE OBSERVED AND THE VALVE WAS DETACHED FROM ONE THIRD OF THE ANNULUS. THE PLEDGETS AND FELTS HAD BEEN LEFT FROM THE PREVIOUS VALVE AND THE PHYSICIAN SUSPECTS THIS MAY HAVE CAUSED THE ENDOCARDITIS. THE PT IS REPORTED TO BE RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208817 TRIFECTA STENTED TISSUE VALVE STENTED TISSUE VALVE LWR ST. JUDE MEDICAL BRASIL LTDA. TF-21A

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R