BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE AORTIC VALVE PROSTHESIS

    MDR report key: 1011235 · Received February 5, 2008

    Report

    Report Number
    1011235
    Event Type
    Malfunction
    Date Received
    February 5, 2008
    Date of Event
    January 25, 2008
    Report Date
    February 5, 2008
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT. UNDERGOING OPEN HEART SURGERY UTILIZING TEE. INTRAOPERATIVELY, THE TEE REVEALED AORTIC VALVE TO BE HEAVILY CALCIFIED AND SCLEROTIC. IT WAS MOST LIKELY TRILEAFLET IN NATURE WITH A FUSED COMMISSURE. COLOR FLOW DOPPLER SHOWED A 2+ ECCENTRIC REGURGITATION. THE PHYSICIAN WAS UNABLE TOOBTAIN A TRANSVALVULAR CONTINUOUS WAVE DOPPLER, AND THEREFORE WAS UNABLE TO CALCULATE A VALVE AREA. ON VISUAL INSPECTION THE VALVE APPEARED TO BE SEVERELY STENOTIC. PREOPERATIVELY, A VALVE AREA OF 0.8 CM WAS CALCULATED. UPON COMPLETION OF THE PROCEDURE A 2D ECHO SHOWED THE WELL BEATING LEFT VENTRICLE, BUT AN ESSENTIALLY AKINETIC RIGHT VENTRICLE. AT THIS POINT, COLOR FLOW DOPPLER OF THE AORTIC VALVE SHOWED A 2 TO 3+ECCENTRIC, ANTERIORLY-DIRECTED REGURGITANT JET ACROSS THE AORTIC VALVE. NOFURTHER EXAM WAS POSSIBLE. PRIOR TO REINITIATING CARDIOPULMONARY BYPASS, THE INITIALLY IMPLANTED AORTIC VALVE PROSTHESIS WAS REMOVED AND REPLACED WITH A NEW ATS MECHANICAL VALVE CONDUIT SHOWING A WELL FUNCTIONING AORTIC VALVE PROSTHESIS WITH TWO FUNCTIONING VALVE LEAFLETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE AORTIC VALVE PROSTHESIS VALVE, AORTIC LWR MEDTRONIC, INC. 995-25MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR