BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATS MEDICAL, INC

    MDR report key: 370091 · Received January 8, 2002

    Report

    Report Number
    2134151-2002-00001
    Event Type
    Death
    Date Received
    January 8, 2002
    Date of Event
    December 5, 2001
    Report Date
    January 7, 2002
    Manufacturer
    ATS MEDICAL, INC
    Product Code
    LWQ
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED A 24MM AORTIC VALVE IN REVERSED POSITION, THE PATIENT'S AORTA WAS CLOSED AND WEANING FROM THE BYPASS PUMP BEGAN. WHEN PRESSURE IN THE HEART CHAMBERS APPEARED INCORRECT, THE SURGEON REOPENED THE AORTA AND PLACED A NEW VALVE IN THE PROPER POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATS MEDICAL, INC MECHANICAL HEART VALVE LWQ ATS MEDICAL, INC 501 DA24 *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death