BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCCARTHY MYXO ETLOGIX ANNULOPLASTY RING

    MDR report key: 1023255 · Received March 31, 2008

    Report

    Report Number
    6000002-2008-06385
    Event Type
    Injury
    Date Received
    March 31, 2008
    Report Date
    March 19, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    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

    REPORTEDLY, THIS DEVICE WAS EXPLANTED AT IMPLANT DUE TO PHYSICIAN HAVING DIFFICULTY PLACING SUTURE INTO THE RING AT COMMISSURAL AREA. WHEN PARACHUTING DEVICE INTO PLACE THE COMMISSURAL SUTURE PULLED THROUGH THE ANNULUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCCARTHY MYXO ETLOGIX ANNULOPLASTY RING REPLACEMENT HEART VALVE KRH EDWARDS LIFESCIENCES 5100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention