BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING

    MDR report key: 1962220 · Received January 17, 2011

    Report

    Report Number
    2015691-2011-14694
    Event Type
    Injury
    Date Received
    January 17, 2011
    Date of Event
    July 19, 2010
    Report Date
    December 20, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K083470
    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: NO FURTHER DETAILS WERE PROVIDED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. 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 ANNULOPLASTY RING WAS REPLACED BY A VALVE SIX (6) DAYS POST-OPERATIVELY AND THERE HAS BEEN NO REPORT OF A PRODUCT MALFUNCTION.

    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 6 DAYS (0.20 MONTHS) DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 5200 R-10C0535

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R