BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    MDR report key: 1082104 · Received July 24, 2008

    Report

    Report Number
    6000002-2008-08170
    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 TRICUSPID VALVE REPAIR INVOLVING A MODEL 4900 28MM THAT WAS EXPLANTED IN 2008. THE REASON FOR THE EXPLANT IS UNK; HOWEVER, IT WAS REPLACED WITH THE MODEL INDICATED IN THE REPORT. THE PT HAD A REPLACEMENT HEART VALVE IMPLANTED. PLEASE REFER TO MEDWATCH NUMBERS 6000002-2008-08166 AND 6000002-2008-08163.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPIRED IN 2007, APPROX 1 DAY POST-OP DUE TO UNK REASONS. AT THE TIME OF THE PT DEMISE, THE PT HAD ANOTHER DEVICE IMPLANTED IN THE MITRAL POSITION. PLEASE REFER TO MEDWATCH NUMBER 6000002-2008-08163. THIS PT ADDITIONALLY HAD RING REPAIR ON THE TRICUSPID VALVE THAT WAS EXPLANTED AND REPLACED WITH THE DEVICE INDICATED IN THIS REPORT. PLEASE REFER TO MEDWATCH NUMBER 6000002-2008-08166. TWO FOLLOW UP ATTEMPTS WERE MADE OBTAIN ADDITIONAL 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 5L2125

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death