BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM EPIC STENTED PORCINE HEART VALVE

    MDR report key: 3113725 · Received May 10, 2013

    Report

    Report Number
    3001743903-2013-00026
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 13, 2013
    Report Date
    April 23, 2013
    Manufacturer
    ST JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT REOPERATION DUE TO HIGH GRADIENT. THE GRAFT THAT HAD BEEN IMPLANTED HAD PROLAPSED INTO THE FLOW AREA WAS ADJUSTED. THE VALVE WAS REPLACED BY AN SJM REGENT MECHANICAL VALVE. AT EXPLANT, PANNUS WAS OBSERVED UNDER THE CUSPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207638 SJM EPIC STENTED PORCINE HEART VALVE STENTED TISSUE VALVE LWR ST JUDE MEDICAL BRASIL LTDA. E100-23A

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R