BEUDAMED
    FDA Adverse Event Death Summary report: N

    SJM REGENT HEART VALVE

    MDR report key: 2010473 · Received March 1, 2011

    Report

    Report Number
    2648612-2011-00018
    Event Type
    Death
    Date Received
    March 1, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC. (CS)
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, ON (B)(6) 2011, THE PT PRESENTED WITH CHEST PAIN, SYNCOPE, INCREASING SHORTNESS OF BREATH ON EXERTION, ORTHOPNEA, 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. TREATMENT WAS ADMINISTERED FOR ENDOCARDITIS AND THE PT UNDERWENT CORONARY ARTERY BYPASS AND THIS VALVE WAS IMPLANTED ON (B)(6) 2011. ON (B)(6) 2011, ECHOCARDIOGRAM REVEALED AN AORTIC PRESSURE GRADIENT OF 25-30 MMHG. FLUOROSCOPY ON (B)(6) 2011 SHOWED THE MECHANICAL VALVE WAS NOT FUNCTIONING OPTIMALLY (CAUSE UNK). THE PT WAS SCHEDULED FOR A TRANSESOPHAGEAL ECHOCARDIOGRAM FOR FURTHER EVALUATION OF THE VALVE AND AORTIC VALVE SURGERY. THE PT SUFFERED CARDIAC ARREST AND DEATH ON (B)(6) 2011. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM REGENT HEART VALVE REGENT ROTATABLE VALVE LWQ ST. JUDE MEDICAL PUERTO RICO, INC. (CS) 21AGN-751

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death