BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFENET

    MDR report key: 34779 · Received July 10, 1996

    Report

    Report Number
    34779
    Event Type
    Death
    Date Received
    July 10, 1996
    Date of Event
    June 21, 1996
    Report Date
    July 9, 1996
    Manufacturer
    LIFENET
    Product Code
    MIE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    06/11/96 AORTIC VALVE AND ASCENDING AORTA REPLACED WITH HOMOGRAFT. PT CONVALESCED WELL POST-OPERATIVELY UNTIL 6/21/96. PT FOUND ON FLOOR, PULSELESS. FIFTEEN MINUTES EARLIER SHE WAS ALERT, ORIENTED AND WITH GOOD PULSE OXIMETRY ON 4 LITERS OXYGEN. RESUSCITATION INCLUDING OPEN CARDIAC MASSAGE WAS PERFORMED. BLEEDING FROM THE AORTIC SUTURE LINE WAS NOTED AND THE PT WAS BROUGHT TO THE OR. OPERATIVE FINDINGS INCLUDED A MASSIVE TAMPONADE AND BLEEDING FROM THE DISTAL SUTURE LINE BETWEEN THE ASCENDING AORTA AND THE HOMOGRAFT. THE PT WAS PLACED ON BYPASS AND THE TEAR FROM THE DISTAL SUTURE LINE WAS SUTURED. THE PT DID NOT IMPROVE AND RESUSCITATION MEASURES WERE STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFENET AORTIC VALVE MIE LIFENET

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death