BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 1212033 · Received October 24, 2008

    Report

    Report Number
    MW5008773
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    October 23, 2008
    Report Date
    October 23, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ST. JUDE REGENT AORTIC VALVE SEATED IN PLACE IN ROUTINE MANNER. STITCHES PLACED, AS EACH STITCH TIED DOWN SURGEON CHECKED FOR FREE MOVEMENT OF LEAFLET. AFTER ONE TIE DOWN LEAFLET WOULD NOT OPEN. SURGEON PLACED VALVE STEM HANDLE ONTO VALVE TO ROTATE. DURING ATTEMPTED ROTATION ONE LEAFLET BROKE OFF. HEART, CHEST, PERICARDIUM ALL EXPLORED FOR LEAFLET. STERILE FIELD SPONGES, DRAPES, TOWELS, FLOOR ALL SEARCHES, LEAFLET NOT FOUND. NURSING CLINICIANS UNABLE TO DETERMINE PRODUCT MALFUNCTION VS USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL AORTIC MECHANICAL VALVE LWQ ST. JUDE MEDICAL REGENT

    Patients

    Seq Age Sex Outcome Treatment
    1