BEUDAMED
    FDA Adverse Event Death Summary report: N

    SJM BIOCOR SUPRA STENTED VALVE W/ FLEXFIT SYSTEM

    MDR report key: 3191029 · Received June 21, 2013

    Report

    Report Number
    3001743903-2013-00030
    Event Type
    Death
    Date Received
    June 21, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ST JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT EXPIRED POSTOPERATIVELY FROM HEART FAILURE, ALLEGEDLY AS A RESULT OF AORTIC VALVE THROMBOSIS. THE AUTOPSY WAS PERFORMED ON (B)(6) 2013. IT WAS REPORTED THE PT WAS COMPLIANT WITH ANTI-COAGULANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283630 SJM BIOCOR SUPRA STENTED VALVE W/ FLEXFIT SYSTEM STENTED TISSUE VALVE LWR ST JUDE MEDICAL BRASIL LTDA. BSP100-23 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death