BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH DURAFLO TREATMENT

    MDR report key: 1992746 · Received February 16, 2011

    Report

    Report Number
    2015691-2011-14803
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    September 14, 2010
    Report Date
    January 17, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K980487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. IN THE SURGEON'S RESPONSE, HE INDICATED THAT THE DEVICE WAS NOT AVAILABLE FOR RETURN. EXPLANTS OF RINGS AT SOMETIME DURING A POSTOPERATIVE PERIOD ARE TYPICALLY PERFORMED FOR A FAILED VALVULOPLASTY REPAIR. IN THIS CASE, THE SURGEON INDICATED THAT THIS EXPLANT WAS NOT DUE TO A DEVICE MALFUNCTION. THE RING WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 YEARS AND WAS REPLACED BY A VALVE.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED 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 DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 YEARS. ON (B)(6) 2011, A RESPONSE WAS RECEIVED FROM THE SURGEON INDICATING THAT THE DEVICE WAS EXPLANTED DUE TO AN UNSUCCESSFUL RING REPAIR AND WAS NOT A MALFUNCTION OF THE DEVICE. THIS IS A CASE OF REOCCURRING MITRAL REGURGITATION "DUE TO RETRACTION AND FIXATION OF THE POSTERIOR MITRAL VALVE LEAFLET WITH LOSS OF COAPTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH DURAFLO TREATMENT ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4475 5D0855

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R