BEUDAMED
    FDA Adverse Event Death Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1729574 · Received June 16, 2010

    Report

    Report Number
    2025587-2010-00053
    Event Type
    Death
    Date Received
    June 16, 2010
    Report Date
    May 18, 2010
    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

    (B) (4). METHOD: DEVICE HISTORY REVIEWED. RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS VALVE MET ALL MFG SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. WITHOUT THE RETURN OF THE PRODUCT, NO CONCLUSIONS CAN BE DRAWN ABOUT THE PERFORMANCE OF THE VALVE. A TRANS-ESOPHAGEAL ECHOCARDIOGRAPHIC (TEE) EVALUATION TAKEN DURING THE PROCEDURE REVEALED MILD PARAVALVULAR AORTIC REGURGITATION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT AORTIC INSUFFICIENCY WAS NOTED IMMEDIATELY POST IMPLANT OF THIS BIOPROSTHETIC VALVE. THE VALVE WAS EXPLANTED AND REPLACED WITH A MECHANICAL VALVE AND CONDUIT. IT WAS REPORTED THAT THE PT DIED INTRA-OPERATIVELY DUE TO BLEEDING. IT WAS ALSO REPORTED THAT THE PT HAD A HEAVILY CALCIFIED AORTA WITH VERY FRIABLE TISSUE.

    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