BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM EPIC SUPRA STENTED PORCINE HEART VALVE

    MDR report key: 1180465 · Received September 26, 2008

    Report

    Report Number
    3001743903-2008-00049
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ST JUDE MEDICAL BRASIL LTD.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITALS PATHOLOGY DEPARTMENT, THE VALVE WAS EXPLANTED AND UPON GROSS EXAMINATION, FIBRIN DEPOSITS WERE OBSERVED ON THE VALVE. THE PATHOLOGY DEPARTMENT WAS UNAWARE OF THE REASON FOR EXPLANT. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM EPIC SUPRA STENTED PORCINE HEART VALVE STENTED TISSUE VALVE LWR ST JUDE MEDICAL BRASIL LTD. ESP100-25-00

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R