BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING

    MDR report key: 1920210 · Received December 10, 2010

    Report

    Report Number
    2015691-2010-14513
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    August 30, 2010
    Report Date
    November 12, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K912554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED, DISCARDED BY HOSPITAL. NO SURGEON OR FOLLOW UP DOCTOR CONTACT INFORMATION WAS PROVIDED. NO FURTHER DETAILS WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE HOSPITAL. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. 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, AND PROCEDURE FACTORS. IT IS TYPICALLY NOT RELATED TO PRODUCT MALFUNCTION. IN THIS CASE, THE ROOT CAUSE FOR THE EXPLANT OF THIS DEVICE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    AN EVENT WAS RECEIVED THROUGH THE EDWARDS LIFESCIENCES (B)(4) IMPLANT PATIENT REGISTRY. THIS "REGISTRY" IS A PATIENT TRACKING MECHANISM FOR SERIALIZED DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET REGISTRY. PATIENT AND DEVICE STATUS ARE REPORTED THROUGH THE REGISTRY. THIS INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED BY EDWARDS AS A CONVENTIONAL CUSTOMER COMPLAINT. IN THIS CASE, THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 12 YEARS (146.37 MONTHS) AND WAS REPLACED BY A VALVE. THE REASON FOR EXPLANT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4400 97A012

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R