BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    MDR report key: 1030005 · Received April 14, 2008

    Report

    Report Number
    6000002-2008-06518
    Event Type
    Death
    Date Received
    April 14, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 13, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, PATIENT EXPIRED AFTER AN IMPLANT DURATION OF 0.03 MONTH, DUE TO UNKNOWN REASONS. UNKNOWN IF PATIENT DEATH IS DEVICE RELATED. INFORMATION LEARNED FROM IMPLANT PATIENT REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4900T34 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death