BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING

    MDR report key: 1211466 · Received October 23, 2008

    Report

    Report Number
    6000002-2008-09018
    Event Type
    Death
    Date Received
    October 23, 2008
    Date of Event
    November 11, 2007
    Report Date
    October 7, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K926138
    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

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED APPROXIMATELY AFTER IMPLANT DURATION OF 2 MONTHS, DUE TO UNKNOWN REASONS. IT IS UNKNOWN IF THE DEATH WS DEVICE RELATED. IT WAS ADDITIONALLY REPORTED THAT A SECOND DEVICE, MODEL #3000TFX, WAS EXPLANTED. REFER TO MFR #6000002-20080-09017. NO FURTHER DETAILS WERE PROVIDED. INFORMATION LEARNED FROM IMPLANT PATIENT REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4450 58256024

    Patients

    Seq Age Sex Outcome Treatment
    1 Death