BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    MDR report key: 1051816 · Received May 21, 2008

    Report

    Report Number
    6000002-2008-07266
    Event Type
    Death
    Date Received
    May 21, 2008
    Date of Event
    June 15, 2007
    Report Date
    January 9, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K020864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THAT THE PT EXPIRED IN 2007 AFTER AN IMPLANT DURATION OF 11 DAYS. THIS INFO WAS PROVIDED BY THE PT'S WIFE. NO OTHER DETAILS WERE PROVIDED. TWO ATTEMPTS WERE MADE TO OBTAIN ADD'L INFO FROM THE SURGEON'S OFFICE CONCERNING THE REPORTED EVENT; HOWEVER, NO INFO WAS FORTHCOMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM ANNULOPLASTY SYSTEM KRH EDWARDS LIFESCIENCES 4900 6L0602

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death