BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    MDR report key: 1940009 · Received December 28, 2010

    Report

    Report Number
    2015691-2010-14593
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    October 22, 2010
    Report Date
    December 1, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K923367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE HOSPITAL DID NOT RECORD THE DEVICE SERIAL NUMBER; THEREFORE, THE DHR CANNOT BE DONE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE HOSPITAL. EXPLANTS OF RINGS AT SOMETIME DURING A POSTOPERATIVE PERIOD (> 0 DAYS) ARE TYPICALLY PERFORMED FOR A FAILED VALVULOPLASTY REPAIR. ALTHOUGH THESE TYPICALLY DO NOT REPRESENT A MALFUNCTION OF THE ANNULOPLASTY RING, THEY DO REQUIRE REOPERATION. THIS EVENT WAS REPORTED AS IT IS CONSIDERED A SERIOUS INJURY. IN THIS CASE, THE 4600G-28MM ANNULOPLASTY RING WAS EXPLANTED AND REPLACED BY A 4900T-30MM ANNULOPLASTY RING (LARGER SIZE AND DIFFERENT MODEL) AFTER APPROXIMATELY 4 YEARS FOR UNKNOWN REASONS. THERE WAS NO REPORT OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    AN EVENT WAS RECEIVED THROUGH THE (B)(4). 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 4 YEARS (50.23 MONTHS) DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSGROVE-EDWARDS ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4600

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| R