BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    MDR report key: 1040249 · Received May 7, 2008

    Report

    Report Number
    6000002-2008-07067
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    May 31, 2005
    Report Date
    September 18, 2007
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 AFTER AN IMPLANT DURATION OF ZERO DAYS DUE REGURGITATION STILL PRESENT. REPAIR FAILED, DUE TO TETHERING OF LEAFLETS. REPLACED WITH PROSTHETIC VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING ANNULOPLASTY RINGS KRH EDWARDS LIFESCIENCES 4450 R07K1957

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention