BEUDAMED
    FDA Adverse Event Injury Summary report: N

    20 ATS VALVE

    MDR report key: 442031 · Received February 5, 2003

    Report

    Report Number
    MW1027482
    Event Type
    Injury
    Date Received
    February 5, 2003
    Date of Event
    December 16, 2002
    Report Date
    January 30, 2003
    Manufacturer
    ATS MEDICAL, INC.
    Product Code
    LWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT. ADMITTED TO HOSPITAL WITH AV VALVE THROMBOSIS, CHF, CARDIAC CATH COMPLETED. SHOWED SIGNIFICANT RESTRICTION OF MOTION OF THE POSTERIOR MOTION OF THE POSTERIOR MOST ASPECT OF BILEAFLET VALVE. INTERNALLY INVOLVED WITH VALVE WAS A THROMBUS 12 X 12 MMHG, 1.5. CM ABOVE AORTIC VALVE PLANE AND EXTENDING THROUGH VALVE INTO OUTFLOW TRACT. QUESTION AS TO WHETHER VALVE DOES FUNCTION APPROPRIATELY. VALVE DOES NOT SEEM TO OPEN OR CLOSE COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 20 ATS VALVE HEART VALVE LWQ ATS MEDICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization