BEUDAMED
    FDA Adverse Event Death Summary report: N

    NONE

    MDR report key: 1051531 · Received May 23, 2008

    Report

    Report Number
    3001743903-2008-00023
    Event Type
    Death
    Date Received
    May 23, 2008
    Date of Event
    March 27, 2007
    Report Date
    April 17, 2008
    Manufacturer
    ST JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT RECEIVED A MITRAL VALVE REPLACEMENT IN 1992 AND DEVELOPED STENOSIS AND INSUFFICIENCY WITH CALCIFICATION OF THE VALVE. THE VALVE WAS EXPLANTED IN 2007 AND REPLACED WITH THE REFERENCED VALVE. DURING IMPLANTATION, THE PT DEVELOPED A LEAK. THE SURGEON ATTEMPTED TO REPAIR THE LEAK TWICE BRINGING THE PT ON AND OFF BYPASS. THERE WAS A PERSISTENT LEAK, AND THE SURGEON OPTED TO REMOVE THE VALVE AND REPLACE WITH A BOVINE PERICARDIAL VALVE. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE LWR ST JUDE MEDICAL BRASIL LTDA. B10-31M

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R