BEUDAMED
    FDA Adverse Event Death Summary report: N

    ST. JUDE MEDICAL AORTIC VALVE

    MDR report key: 2005725 · Received February 15, 2011

    Report

    Report Number
    2005725
    Event Type
    Death
    Date Received
    February 15, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 8, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) Y.O. MALE TYPE 1 DIABETIC ADMITTED ON (B)(6) 2011 THROUGH EMERGENCY DEPARTMENT WITH CHEST PAIN, SYNCOPE, INCREASING SHORTNESS OF BREATH WITH EXERTION, ORTHOPNEA, SYNCOPE, SUBACUTE ENDOCARDITIS, AND POSITIVE TROPONIN LAB VALUES. CARDIAC CATHETERIZATION REVEALED DECREASED LEFT VENTRICULAR FUNCTION WITH EJECTION FRACTION APPROX 35%, AORTIC INSUFFICIENCY, PULMONARY HYPERTENSION, AND CORONARY ARTERY DISEASE IN MULTIPLE VESSELS. BEGAN TREATMENT FOR ENDOCARDITIS AND TAKEN FOR CORONARY ARTERY BYPASS AND AORTIC VALVE REPLACEMENT WITH MECHANICAL VALVE ON (B)(6) 2011. ON (B)(6) 2011, ECHOCARDIOGRAM REVEALED AORTIC PRESSURE GRADIENT OF 25-30MMHG. FLUOROSCOPY ON (B)(6) 2011 SHOWED MECHANICAL VALVE NOT FUNCTIONING OPTIMALLY - CAUSE UNK. VALVE MANUFACTURER CONSULTED. PT SCHEDULED FOR TRANSESOPHAGEAL ECHOCARDIOGRAM FOR FURTHER EVALUATION OF THE VALVE AND AORTIC VALVE SURGERY. PT SUFFERED CARDIAC ARREST AND DEATH ON (B)(6) 2011, PRIOR TO THESE BEING DONE. AUTOPSY IS PENDING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death