BEUDAMED
    FDA Adverse Event Death Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1133003 · Received August 21, 2008

    Report

    Report Number
    2025587-2008-00077
    Event Type
    Death
    Date Received
    August 21, 2008
    Report Date
    August 21, 2008
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION = EXACT CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: THE DEVICE WAS NOT EXPLANTED, AND WILL THEREFORE NOT BE RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THIS PRODUCT MET MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE TEE WAS EVALUATED BY AN INDEPENDENT PHYSICIAN, WHO DESCRIBED HEMODYNAMIC EVIDENCE OF SEVERE BIOPROSTHESIS STENOSIS, WITH ASSOCIATED SEVERE LEFT VENTRICULAR SYSTOLIC DYSFUNCTION OF UNK CHRONICITY, TEE DEMONSTRATES DIFFUSE CUSP THICKENING AND DECREASED CUSP EXCURSION WITH ASSOCIATED MOBILE COMPONENTS. OCCURRING IN THE CLINICAL SETTING VERY EARLY AFTER VALVE IMPLANTATION, THE DIFFERENTIAL DIAGNOSIS FOR THESE FINDINGS INCLUDE BIOPROSTHESIS THROMBOSIS VS INFECTIVE ENDOCARDITIS WITH VALVULAR VEGETATIONS. CONCLUSION: UNABLE TO DETERMINE THE EXACT CAUSE FOR THE REPORTED EVENT, AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. HOWEVER, REDUCED PERFORMANCE OF THE DEVICE LIKELY ATTRIBUTED TO THROMBOSIS AND/OR ENDOCARDITIS, BOTH OF WHICH ARE IDENTIFIED IN THE IFU AS POSSIBLE ADVERSE EVENTS ASSOCIATED WITH USAGE OF BIOPROSTHETIC VALVES.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS BIOPROSTHETIC AORTIC VALVE WAS IMPLANTED IN 2008 WITHOUT COMPLICATION. INTRAOPERATIVE AND POSTOPERATIVE ECHOCARDIOGRAMS APPEARED NORMAL, DEMONSTRATING NORMAL GRADIENTS AND NORMAL FUNCTION. THE PT WAS SUBSEQUENTLY DISCHARGED. APPROX 3 MONTHS LATER, THE PT WAS RE-ADMITTED WITH SYMPTOMS OF HEART FAILURE. AN ECHO TAKEN UPON ADMISSION DEMONSTRATED PEAK GRADIENTS OF 90MMHG AND A MEAN GRADIENT OF 40MMHG. THE VALVE LEAFLETS APPEARED THICKENED AND IMMOBILE. THE PT REPORTEDLY EXPIRED AROUND 3 A.M. THE FOLLOWING MORNING. NO AUTOPSY WAS PERFORMED. A TRANS-ESOPHAGEAL ECHO WAS OBTAINED PRIOR TO THE PT'S DEATH, AND HAS BEEN RETURNED TO MEDTRONIC FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE LWR MEDTRONIC HEART VALVES, INC. 305 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death