BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    MDR report key: 724568 · Received June 9, 2006

    Report

    Report Number
    6000002-2006-00328
    Event Type
    Injury
    Date Received
    June 9, 2006
    Date of Event
    February 28, 2006
    Report Date
    May 12, 2006
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI

    Narratives

    Additional Manufacturer Narrative · 1

    F1: USER FACILITY, F2: UNK, F3: HENERY FORD HOSPITAL 2799 W. GRAND BLVD, DETROIT, MI 48202, 313-916-2600, F4: SEE E1, F5: SEE E1. H6: #86: DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, THIS RING WAS EXPLANTED AFTER APPROX A 4 MONTH IMPLANT DURATION DUE TO A PARAVALVULAR LEAK AND MITRAL REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSGROVE-EDWARDS ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4600 5J1718

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention