BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    MDR report key: 1897150 · Received November 11, 2010

    Report

    Report Number
    2015691-2010-14354
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    April 6, 2010
    Report Date
    October 13, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K926138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. AN OPERATIVE REPORT WAS REQUESTED BUT NOT PROVIDED. THE DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED BY THE HOSPITAL. WITH THE MINIMAL INFORMATION PROVIDED, A COMPLETE EVALUATION CANNOT BE PERFORMED. HOWEVER, THE SURGEON INDICATED THAT THE RING DID NOT CONTRIBUTE TO THE EVENT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND IT WAS CONFIRMED THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS DURING PRODUCTION.

    Description of Event or Problem · 1

    AN EVENT WAS RECEIVED THROUGH THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY. THIS "REGISTRY" IS A PATIENT TRACKING MECHANISM FOR SERIALIZED DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET REGISTRY. PATIENT AND DEVICE STATUS ARE REPORTED THROUGH THE REGISTRY. THIS INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED BY EDWARDS AS A CONVENTIONAL CUSTOMER COMPLAINT. IN THIS CASE, IT WAS REPORTED THAT THE ANNULOPLASTY RING WAS EXPLANTED AFTER APPROXIMATELY 5 YEARS. ACCORDING TO FOLLOW-UP WITH THE HEALTH CARE PROVIDER, THE DEVICE WAS EXPLANTED DUE TO RESIDUAL MITRAL REGURGITATION (MR) AND ASSOCIATED TRICUSPID REGURGITATION (TR). THE ANNULOPLASTY RING WAS REPLACED WITH AN EDWARDS VALVE. THE SURGEON INDICATED THAT THE RING DID NOT CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4450 04M045

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R