BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATS MEDICAL, INC.

    MDR report key: 698524 · Received April 11, 2006

    Report

    Report Number
    2134151-2006-00003
    Event Type
    Other
    Date Received
    April 11, 2006
    Date of Event
    August 9, 2005
    Report Date
    April 11, 2006
    Manufacturer
    ATS MEDICAL, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFRER MVR WITH PROSTHETIC VALVE ATS SIZE 27 AND DURING TESTING THE VALVE WITH THE PLASTIC BAR, ONE LEAFLET DROPPED IN THE LEFT VENTRICLE. DURING TRIAL TO EXTRACT IT FROM VL, THE LEAFLET BROKE IN 2 PIECES. THE VALVE WAS REMOVED AND REPLACED WITH ANOTHER NEW ONE OF THE SAME TYPE AND SIZE; ATS 27. THE DAMAGED VALVE WAS RETURNED TO ATS MEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATS MEDICAL, INC. MECHANICAL HEART VALVE LWQ ATS MEDICAL, INC. 500DM27 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention