BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCOR STENTED PROCINE HEART VALVE

    MDR report key: 2850587 · Received November 16, 2012

    Report

    Report Number
    3001743903-2012-00073
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    ST. JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED TO SJM INDICATED THE PT PRESENTED WITH MITRAL REGURGITATION DUE TO A TORN LEAFLET. THE PREGNANT PT UNDERWENT RE-DO MITRAL VALVE REPLACEMENT SURGERY AND THE VALVE WAS REMOVED AND REPLACED WITH AN SJM MECHANICAL VALVE. IT WAS REPORTED THE PT IS RECOVERING WELL; HOWEVER, THE UNBORN CHILD DID NOT SURVIVE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOCOR STENTED PROCINE HEART VALVE STENTED TISSUE VALVE LWR ST. JUDE MEDICAL BRASIL LTDA. B100-33M-00

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R