BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    MDR report key: 1082107 · Received July 24, 2008

    Report

    Report Number
    6000002-2008-08166
    Event Type
    Death
    Date Received
    July 24, 2008
    Date of Event
    May 2, 2007
    Report Date
    January 3, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K020864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. REPORTEDLY, AT THE TIME OF IMPLANTATION OF THE DEVICE, THE PT HAD MITRAL VALVE REPLACEMENT. PLEASE REFER TO MEDWATCH NUMBER 6000002-2008-08163. THE EXPLANTED RING WAS REPLACED WITH A 4900/26MM. PLEASE REFER TO MEDWATCH NUMBER 6000002-2008-08170.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPIRED ON 05/02/2007, APPROX 1 DAY POST-OP DUE TO UNK REASONS. THE REPORTED DEVICE WAS IMPLANTED AND EXPLANTED ON 5/1/2007 DUE TO UNK REASONS. IT WAS REPLACED WITH THE MODEL 4900T26MM (REFER TO MEDWATCH NUMBER 6000002-2008-08170). A REPLACEMENT HEART VALVE WAS IMPLANTED IN THE MITRAL POSITION ON THE SAME DAY. PLEASE REFER TO MEDWATCH NUMBER 6000002-2008-08163. TWO FOLLOW UP ATTEMPTS WERE MADE OBTAIN ADD'L INFO CONCERNING THE REPORTED EVENT. NO OTHER INFO WAS FORTHCOMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM TRICUSPID ANNULOPLASTY SYSTEM KRH EDWARDS LIFESCIENCES 4900T 5F1153

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| R