BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX MITRAL ANNULOPLASTY RING

    MDR report key: 2080933 · Received May 8, 2011

    Report

    Report Number
    2015691-2011-15490
    Event Type
    Injury
    Date Received
    May 8, 2011
    Date of Event
    November 13, 2010
    Report Date
    April 9, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K083623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: DESPITE OUR ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO RESPONSE OR SAMPLE FOR EVALUATION WAS RECEIVED FROM THE HEALTH-CARE PROVIDER. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR STERILIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, THE ANNULOPLASTY RING WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 MONTHS 18 DAYS (3.60 MONTHS) AND WAS REPLACED BY A 7000TFX VALVE DUE TO UNKNOWN REASONS. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX MITRAL ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4100 10B035

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R