BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING

    MDR report key: 1212079 · Received October 23, 2008

    Report

    Report Number
    6000002-2008-09031
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 17, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K926138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED APPROX AFTER IMPLANT DURATION OF 7.73 MOS, DUE TO MITRAL INSUFFICIENCY. NO FURTHER DETAILS WERE PROVIDED. INFO LEARNED FROM OPERATIVE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4450 R07H1604

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention