BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-X MITRAL PROSTHETIC HEART VALVE

    MDR report key: 1437197 · Received March 6, 2009

    Report

    Report Number
    1649833-2009-00001
    Event Type
    Death
    Date Received
    March 6, 2009
    Date of Event
    January 24, 2009
    Report Date
    March 5, 2009
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO POST-MORTEM DONE. VALVE CANNOT BE OBTAINED FOR RETURN AND FURTHER ANALYSIS.

    Description of Event or Problem · 1

    VALVE ORIGINALLY IMPLANTED IN 2009. SHE WAS KNOWN TO BE WELL ANTI-COAGULATED. SHE BECAME PREGNANT AND HAD NORMAL DELIVERY EIGHT MONTHS EARLIER. MOTHER AND BABY FINE. SHE HAD NOT INFORMED MEDICAL STAFF THAT SHE HAD BEEN ON WARFARIN DURING THE PREGNANCY. TEN DAYS LATER, SHE WAS ADMITTED TO THE HOSPITAL VERY SHORT OF BREATH IN CARDIAC FAILURE, AND THE MEDICAL OFFICER ATTENDING TO HER IS VERY JUNIOR AND THEREFORE, DID NOT RECOGNIZE THE SYMPTOMS OF A POTENTIALLY CLOTTING VALVE. THE DOCTOR CALLED TO ARRANGE FOR AN AMBULANCE TO BRING HER TO A DIFFERENT FACILITY, BUT THE PT DIED ON THE WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-X MITRAL PROSTHETIC HEART VALVE MECHANICAL HEART VALVE LWQ ON-X LIFE TECHNOLOGIES, INC. ONXM

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Death