BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    MDR report key: 1984358 · Received February 10, 2011

    Report

    Report Number
    2015691-2011-14773
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    August 25, 2010
    Report Date
    January 13, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K926138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. NO ADDITIONAL INFORMATION IS KNOWN ABOUT THE EVENT. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED. THE REASON FOR EXPLANT HAS NOT BEEN CONFIRMED BY THE EXPLANT SURGEON. 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 EXPLANTED A SIZE 32MM DEVICE AND REPLACED IT WITH A SMALLER SIZE OF THE SAME MODEL DEVICE.

    Additional Manufacturer Narrative · 1

    IT HAS BEEN LEARNED THOUGH FOLLOW-UP WITH THE HEALTHCARE PROVIDER THAT THE DEVICE DID NOT CONTRIBUTE TO THE EVENT. THIS EVENT WAS REPORTED IN ERROR.

    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 ANNULOPLASTY RING WAS EXPLANTED AT IMPLANT AND WAS REPLACED WITH A SMALLER SIZE OF THE SAME MODEL DEVICE -- FOR UNKNOWN REASONS.

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED IN ERROR. THROUGH FOLLOW-UP WITH THE HEALTHCARE PROVIDER, IT WAS LEARNED THAT THE EXPLANT WAS DUE TO A SIZING ISSUE, NOT A MALFUNCTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4450 09F169

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R