BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO II RING

    MDR report key: 3930270 · Received July 11, 2014

    Report

    Report Number
    2015691-2014-01576
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    December 16, 2013
    Report Date
    June 13, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K083470
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SYSTOLIC ANTERIOR MOTION (SAM) OF THE MITRAL VALVE. METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THE INSTRUCTIONS FOR USE (IFU) FOR THIS DEVICE WERE REVIEWED AND FOUND TO BE ADEQUATE. WITHOUT THE RETURN OF THE DEVICE OR RECEIPT OF INTRA-OPERATIVE ECHOS, EDWARDS IS UNABLE TO CONFIRM THE CLINICAL OBSERVATION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    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, EDWARDS RECEIVED INFORMATION THAT TWO ANNULOPLASTY RINGS, 32MM AND 38MM, WERE IMPLANTED FOR ONE PATIENT IN THE SAME POSITION WITH THE SAME DATE OF SURGERY. FURTHER INVESTIGATION REVEALED THAT THIS 32MM ANNULOPLASTY RING WAS EXPLANTED AT IMPLANT DUE TO SAM (SYSTOLIC ANTERIOR MOTION) AND RESIDUAL MODERATE MITRAL INSUFFICIENCY OF THE MITRAL VALVE NOTED AFTER DISCONTINUATION OF CARDIOPULMONARY BYPASS AND ADMINISTRATION OF PROTAMINE. A COMBINATION OF FACTORS CONTRIBUTED TO THIS DEVICE EXPLANT INCLUDING SEPTAL HYPERTROPHY AND 32MM RING SELECTION. THE PATIENT WAS PLACED BACK ON BYPASS TO REINTERVENE. AFTER SIZING AGAIN, THE SURGEON IMPLANTED A 38MM RING WITH ACCEPTABLE RESULTS. PATIENT'S POST-OP COURSE WAS COMPLICATED WITH A RETURN TO OR FOR BLEEDING ON POD#2 AND STERNAL DEHISCENCE WITH SUSPICION OF MEDIASTINITIS ONE WEEK POST-OP. THE EXPLANTED DEVICE AND THE INTRA-OP ECHOS ARE NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405898 CARPENTIER-EDWARDS PHYSIO II RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 5200M32

    Patients

    Seq Age Sex Outcome Treatment
    1 61 Required Intervention