BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING

    MDR report key: 2012479 · Received March 10, 2011

    Report

    Report Number
    2015691-2011-14985
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    October 28, 2010
    Report Date
    February 9, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K083470
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. DESPITE ATTEMPTS TO GET ADDITIONAL INFORMATION REGARDING THIS EVENT AND RETURN OF THE PRODUCT FOR EVALUATION, NO PATIENT INFORMATION HAS BEEN PROVIDED AND NO PRODUCT HAS BEEN RETURNED. SURGEONS OFTEN ATTEMPT TO REPAIR VALVES IN LIEU OF REPLACING THEM DUE TO IMPROVED LONG-TERM CLINICAL OUTCOMES. THERE ARE TIMES WHEN A VALVE REPAIR IS ATTEMPTED USING AN ANNULOPLASTY RING AND SUBSEQUENT POST-REPAIR EVALUATION DEMONSTRATES AN INADEQUATE RESULT. THIS IS ALMOST UNIVERSALLY DUE TO SUBOPTIMAL ANATOMY, SURGICAL TECHNIQUE OR INAPPROPRIATE SIZING, AND NOT A MALFUNCTION OF THE ANNULOPLASTY RING. IN THIS CASE, THE SURGEON'S RESPONSE WAS INTERPRETED AS A SIZING ISSUE AND NOT A MALFUNCTION OF THE DEVICE.

    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. ON (B)(6) 2011 A RESPONSE WAS RECEIVED FROM THE SURGEON INDICATING, "HE JUST SWITCHED SIZE ON THE PHYSIO II RING IN ORDER TO GET BETTER COAPTATION AND THEREFORE OPTIMAL SURGICAL RESULT." AND THERE WAS NO REPORT OF A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 5200 9F1246

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization| R