BEUDAMED
    FDA Adverse Event Death Summary report: N

    SJM EPIC STENTED PORCINE HEART VALVE

    MDR report key: 1203024 · Received October 17, 2008

    Report

    Report Number
    3001743903-2008-00054
    Event Type
    Death
    Date Received
    October 17, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 17, 2008
    Manufacturer
    ST JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, THE FEMALE PT, STATUS-POST TWO FAILED CATHETER-BASED PROCEDURES FOR ATRIAL FIBRILLATION, UNDERWENT MITRAL VALVE REPLACEMENT WITH THIS SJM EPIC VALVE AND A TRICUSPID VALVE REPAIR WITH AN EDWARDS-MCCARTHY ANNULOPLASTY RING. BEFORE THE VALVE PROCEDURES, THE SURGEON USED THE SJM EPICOR SYSTEM TO TREAT THE PATIENT'S ATRIAL ARRHYTHMIA WITH THE ULTRA WAND ABLATION DEVICE. LATER THAT EVENING, THE SURGEON WAS CALLED TO SEE THE PT IN THE ICU, WHERE HE HAD TO OPEN HER CHEST AND FOUND THAT SHE HAD EXSANGUINATED FROM A LACERATION TO THE POSTERIOR LEFT VENTRICLE. THE SURGEON WAS CONCERNED THAT THE WAND ABLATION MIGHT HAVE CAUSED THE LACERATION OF THE HEART, AND HE STATED THAT THERE WAS A SLIGHT POSSIBILITY THAT A STRUT FROM THE VALVE CAME THROUGH THE VENTRICLE, BUT THAT WAS HIGHLY UNLIKELY. THERE WAS NO POST-MORTEM CONDUCTED.

    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. E100-33M-00

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death