BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON RSR PERICARDIAL

    MDR report key: 3060018 · Received April 10, 2013

    Report

    Report Number
    MW5029733
    Event Type
    Death
    Date Received
    April 10, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 10, 2013
    Manufacturer
    EDWARDS LIFE SCIENCES LLC
    Product Code
    DYE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN EDWARDS #27 PERICARDIAL BIOPROSTHESIS WAS PLACED AND UPON RESUMING CARDIAC ACTION, IT WAS NOTED THAT SIGNIFICANT CENTRAL AORTIC REGURGITATION WAS OCCURRING WHICH WAS NOT TOLERATED BY THE PT'S POOR VENTRICLE. THIS VALVE WAS REMOVED AND REPLACED WITH A #25 EDWARDS SUPRA-ANNULAR PORCINE PROSTHESIS WITHOUT ANY FURTHER LEAKAGE. DUE TO SEVERE ARRHYTHMIAS, A VENOARTERIAL ECMO WAS PLACED. POST-OPERATIVELY THE PT DEVELOPED HEMOPTYSIS AND HAD NEARLY NO CARDIAC FUNCTION. AN IMPELLA DEVICE WAS PLACED THE FOLLOWING DAY BUT THE PT STILL SUFFERED VERY POOR FLOW. THE FAMILY MADE THE DECISION TO REMOVE LIFE SUPPORT AND THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149817 CARPENTIER-EDWARDS PERIMOUNT THEON RSR PERICARDIAL PERICARDIAL TISSUE HEART VALVE DYE EDWARDS LIFE SCIENCES LLC 2800TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death