BEUDAMED
    FDA Adverse Event Death Summary report: N

    SJM EPIC STENTED PORCINE HEART VALVE

    MDR report key: 3022561 · Received March 22, 2013

    Report

    Report Number
    3009024882-2013-00007
    Event Type
    Death
    Date Received
    March 22, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ST. JUDE MEDICAL COSTA RICA LTDA. (CS)
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE INFO PROVIDED TO SJM INDICATED THE PT UNDERWENT MITRAL VALVE REPLACEMENT WITH THIS VALVE. UPON CLOSING THE PT'S CHEST, IT APPEARED THERE WAS A HOLE IN THE LEFT ATRIUM. THE PT EXPIRED AND THE CAUSE IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119169 SJM EPIC STENTED PORCINE HEART VALVE STENTED TISSUE VALVE LWR ST. JUDE MEDICAL COSTA RICA LTDA. (CS) E100-27M-00

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death