BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CG FUTURE BAND

    MDR report key: 1082357 · Received July 24, 2008

    Report

    Report Number
    2025587-2008-00071
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    April 30, 2008
    Report Date
    July 24, 2008
    Manufacturer
    MEDTRONIC HEART VALVES, INC
    Product Code
    KRH
    PMA / PMN Number
    K011395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD CODE: OTHER= DEVICE HISTORY REVIEWED. RESULTS CODE: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. ANALYSIS: THE DEVICE WAS RECEIVED IN AN EXPLANT KIT. A SMALL SECTION OF THE CLOTH COVERING IS CUT AND/OR TON ADJACENT TO LEFT END OF THE BAND, ON THE INFLOW ASPECT, EXPOSING THE BARE METAL. GLISTENING OFF WHITE PANNUS REMAINS ATTACHED TO THE CLOTH COVER OF THE INFLOW OF ONE OF THE ENDS EXTENDING SLIGHTLY ALONG THE INSIDE OF THE BAND ONTO THE OUTFLOW. RADIOGRAPHY SHOWS NO EVIDENCE OF MINERALIZATION BUT SHOWS A FRACTURE IN THE MIDDLE OF THE BAND. THE DHR FOR THIS DEVICE WAS REVIEWED AND NO ISSUES WERE SHOWN THAT WOULD HAVE IMPACTED THIS EVENT. CONCLUSION: THE ANALYSIS OF THE DEVICE SHOWS THAT THE EVENT WAS LIKELY CAUSED BY PANNUS, A CONDITION ATTRIBUTED TO THE PT. RADIOGRAPHY SHOWS A FRACTURE PRESENT IN THE MIDDLE OF THE BAND. ALTHOUGH IT CANNOT BE DETERMINED WHEN THE FRACTURE OCCURRED OR WHETHER IT CONTRIBUTED TO THE REPORTED PROGRESSION OF REGURGITATION, CHANGES WERE IMPLEMENTED IN SEPTEMBER 2004 TO ADDRESS THIS ISSUE. THESE CHANGES DID NOT APPLY TO THE DEVICE RETURNED FOR THIS EVENT AS IT WAS MANUFACTURED IN JANUARY 2002.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS ANNULOPLASTY BAND WAS REMOVED DUE TO PROGRESSIVE MITRAL INSUFFICIENCY NOTED BY ECHO. IT WAS REPLACED WITH A MEDTRONIC PORCINE VALVE AND NO PT COMPLICATION OR PRODUCT DISSATISFACTION WAS INDICATED. THE DEVICE HAD BEEN IN SERVICE FOR APPROX 5 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CG FUTURE BAND KRH MEDTRONIC HEART VALVES, INC 638B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other