BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOCOR STENTED PORCINE HEART VALVE

    MDR report key: 1242924 · Received November 21, 2008

    Report

    Report Number
    3001743903-2008-00061
    Event Type
    Death
    Date Received
    November 21, 2008
    Date of Event
    November 14, 2008
    Report Date
    November 21, 2008
    Manufacturer
    ST JUDE MEDICAL BASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE VALVE WAS EXPLANTED DUE TO A LARGE AMOUNT OF VEGETATION CONSISTENT WITH ENDOCARDITIS. DURING THE EXPLANT PROCEDURE, A PARAVALVULAR ABSCESS WAS OBSERVED BY THE LEFT ATRIAL APPENDAGE. THERE WAS NO EVIDENCE OF VALVE DEHISCENCE. AFTER THE VALVE WAS REMOVED, ANOTHER 27 MM SJM BIOPROSTHESIS (MODEL B10-27M-00) WAS IMPLANTED, BUT A PARAVALVULAR LEAK WAS OBSERVED DUE TO AN ATRIOVENTRICULAR GROOVE SEPARATION. THE VALVE WAS REMOVED AND ANOTHER 27 MM SJM BIOPROSTHESIS (MODEL B10-27M-00) WAS THEN IMPLANTED. THE PT EXPIRED IN THE EARLY AM THE FOLLOWING MORNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOCOR STENTED PORCINE HEART VALVE STENTED TISSUE VALVE LWR ST JUDE MEDICAL BASIL LTDA. B10-27M-00

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| H| R