BEUDAMED
    FDA Adverse Event Death Summary report: N

    STARR-EDWARDS

    MDR report key: 17755 · Received July 29, 1994

    Report

    Report Number
    17755
    Event Type
    Death
    Date Received
    July 29, 1994
    Date of Event
    May 19, 1994
    Report Date
    July 13, 1994
    Manufacturer
    STARR EDWARDS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT HAD A MITRAL VALVE REPLACEMENT IN 1964 WITH A SILASTIC BALL PROSTHESIS. MAY 10, 1994, THE PT WAS ADMITTED WITH A DIAGNOSIS OF PROSTHETIC VALVE DYSFUNCTION AS THE PRIMARY DIAGNOSIS. ON 5/19/94, THE VALVE WAS REPLACED, THE TRICUSPID VALVE WAS REPAIRED, AND CABG X 2 WAS ALSO DONE. ON 5/20/94, AN EXPLORATORY STERNOTOMY WAS PERFORMED FOR EVACUATION OF HEMORRHAGE. THE DEATH SUMMARY BY THE MD STATES THAT "THE PATIENT EXPIRED ON 5/30/94 OF LOW CARDIAC OUTPUT AND MULTISYSTEM FAILURE."OR REPORT STATED-"VALVE SHOWED SWELLING OF THE BALL WITH PANNUS & GROWTH ON THE STRUTS WITH ALMOST COMPLETE PROSTHETIC STENOSIS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARR-EDWARDS Implant SILASTIC BALL PROSTHESIS STARR EDWARDS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 * Death