BEUDAMED
    FDA Adverse Event Death Summary report: N

    ST JUDE MEDICAL, INC

    MDR report key: 17393 · Received September 8, 1994

    Report

    Report Number
    17393
    Event Type
    Death
    Date Received
    September 8, 1994
    Date of Event
    September 7, 1994
    Report Date
    September 8, 1994
    Manufacturer
    ST JUDE MEDICAL, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AORTIC VALVE SIZE 25 PLACED. LEAFLETS DID NOT APPEAR TO FUNCTION. REMOVED AND SIZE 23 VALVE PLACED. PT HAD SEVERE COAGULOPATHY, DESPITE MAXIMAL SUPPORT BY IABP. PT EXPIRED 1630. APPEARS TO BE VALVE MALFUNCTION. DEATH DUE TO COAGULOPATHY, CARDIAC FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL, INC Implant AORTIC VALVE REPLACEMENT LWQ ST JUDE MEDICAL, INC. 25A-101

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death