BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM EPIC STENTED TISSUE VALVE

    MDR report key: 1242933 · Received November 21, 2008

    Report

    Report Number
    3001743903-2008-00060
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 21, 2008
    Manufacturer
    ST JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE VALVE WAS EXPLANTED DUE TO STENOSIS. UPON EXPLANT, THE SURGEON NOTICED FIBROTIC (TISSUE) FORMATION ON ONE OF THE LEAFLETS. THE VALVE WAS REMOVED AND REPLACED WITH A ST. JUDE MEDICAL MECHANICAL VALVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM EPIC STENTED TISSUE VALVE STENTED TISSUE VALVE LWR ST JUDE MEDICAL BRASIL LTDA. EL-23A

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R