BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    MDR report key: 2073486 · Received May 1, 2011

    Report

    Report Number
    2015691-2011-15401
    Event Type
    Injury
    Date Received
    May 1, 2011
    Date of Event
    October 8, 2010
    Report Date
    April 1, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K980487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 A PHONE CONVERSATION WITH THE SURGEON, THE FOLLOWING STATEMENT WAS PROVIDED: "AT THE FIRST POST-OPERATIVE ECHO ON OCTOBER 1, AN IMPORTANT RESIDUAL MI WAS NOTED. IT WAS DECIDED TO PERFORM A REDO PROCEDURE IN ORDER TO REPLACE THE MITRAL VALVE." THE SURGEON CONFIRMED THAT THE DEVICE WAS EXPLANTED BUT THAT THE EXPLANT WAS NOT DUE TO A DEVICE MALFUNCTION BUT DUE TO RESIDUAL MITRAL REGURGITATION [OF THE NATIVE] DUE TO AN UNSATISFACTORY RESULT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT DISCARDED BY THE HOSPITAL AND THE OPERATIVE REPORT WAS REQUESTED BUT NOT PROVIDED. CONCLUSION: THERE ARE MANY FACTORS THAT COULD RESULT IN THE NEED TO EXPLANT AN ANNULOPLASTY RING AND REPLACE WITH A BIOPROSTHETIC VALVE, THE MOST COMMON OF WHICH IS REGURGITATION. THESE COMPLICATIONS CAN HAVE MANY ROOT CAUSES, INCLUDING BUT NOT LIMITED TO PATIENT FACTORS, (AGE, DISEASE STATES, COMORBIDITIES), PHARMACOLOGICAL FACTORS, OR PROCEDURE FACTORS. IT IS TYPICALLY NOT RELATED TO PRODUCT MALFUNCTION. IN THIS CASE, THE SURGEON HAS INDICATED THAT THIS EXPLANT WAS DUE TO AN UNSATISFACTORY RESULT DUE TO RESIDUAL MITRAL REGURGITATION. HOWEVER, HE IS NOT WILLING TO PROVIDE ADDITIONAL DETAILS OF THE PROCEDURE OR RELATING TO THE PATIENT. THEREFORE, WE ARE UNABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR THE EXPLANT WITHOUT FURTHER INFORMATION FROM THE HEALTH CARE PROVIDER.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR STERILIZED 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, AN ANNULOPLASTY RING WAS EXPLANTED AFTER AN IMPLANT DURATION OF 16 DAYS (0.53 MONTHS) AND WAS REPLACED BY AN EDWARDS VALVE DUE TO REGURGITATION OF THE NATIVE VALVE. FROM A PHONE CONVERSATION WITH THE SURGEON, THE FOLLOWING STATEMENT WAS PROVIDED: "AT THE FIRST POST-OPERATIVE ECHO ON OCTOBER 1, AN IMPORTANT RESIDUAL MI WAS NOTED. IT WAS DECIDED TO PERFORM A REDO PROCEDURE IN ORDER TO REPLACE THE MITRAL VALVE." THE SURGEON ALSO INDICATED THAT THIS EXPLANT WAS NOT DUE TO A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4450 10B048

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R