BEUDAMED
    FDA Adverse Event Death Summary report: N

    SJM EPIC STENTED PORCINE HEART VALVE

    MDR report key: 1651569 · Received April 2, 2010

    Report

    Report Number
    3001743903-2010-00023
    Event Type
    Death
    Date Received
    April 2, 2010
    Date of Event
    February 15, 2010
    Report Date
    April 2, 2010
    Manufacturer
    ST JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THE DEVICE THROMBOSED INTRAOPERATIVELY AS THE SURGEON WAS WEANING THE PT OFF PUMP. THE THROMBOSIS WAS NOTICED ON ECHO BY THE ANESTHESIOLOGIST. ADD'L INFO RECEIVED INDICATED THE VALVE WAS REMOVED AND REPLACED WITH A 27 MM BIOPROSTHESIS FROM ANOTHER MFR. THE SURGEON STATED THAT GIVEN THE FRAGILE PREOPERATIVE STATUS OF THE PT AND COMPLEX SURGICAL PROCEDURE NEEDED, IT IS BELIEVED THAT THE SECOND PUMP RUN, SECOND CROSS CLAMP, AND PROLONGED OPERATING ROOM TIME EXACERBATED POST-PUMP COAGULOPATHY, ACUTE RENAL FAILURE, SHOCK LIVER, AND RESPIRATORY PROBLEMS THAT RESULTED IN HIS DEATH FIVE WEEKS POSTOPERATIVELY ON (B) (6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM EPIC STENTED PORCINE HEART VALVE STENTED TISSUE VALVE LWR ST JUDE MEDICAL BRASIL LTDA. E100-27M-00

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| H| R