BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS LIFESCIENCE

    MDR report key: 2061293 · Received April 12, 2011

    Report

    Report Number
    MW5020258
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Product Code
    DYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING A CABG/MITRAL VALVE MAZE PROCEDURE, A 25MM MITRAL VALVE WAS PLACED IN THE PT. AFTER BEING SEWN IN, THEY FOUND THAT ONE OF THE LEAFLETS WAS DYSFUNCTIONAL NOT PRODUCING THE BLOOD FLOW CORRECTLY THROUGH THE VALVE. IT WAS REMOVED FROM THE PT AND A ST JUDE MECHANICAL MITRAL VALVE WAS PLACED. THERE WAS NO HARM TO THE PT. THE REP FROM EDWARD'S LIFESCIENCE WAS HERE DURING THE PROCEDURE AND REMOVED THE VALVE FROM THE HOSPITAL. IT HAS TO BE RECORDED TO THE COMPANY WITHIN 24HRS. HE WILL SEND A FULL REPORT IN FOR DR (B)(6) TO EVALUATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS LIFESCIENCE EDWARS LIFESCIENCE MITRAL THERMAFIX VALVE DYE 2428149

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR