BEUDAMED
    FDA Adverse Event Death Summary report: N

    HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 1862153 · Received September 30, 2010

    Report

    Report Number
    2025587-2010-00116
    Event Type
    Death
    Date Received
    September 30, 2010
    Date of Event
    June 25, 2010
    Report Date
    September 3, 2010
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: OTHER: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, A PIECE OF PAPILLARY MUSCLE TISSUE, ATTACHED TO A SUTURE, WAS RECEIVED WITH THE VALVE. PART OF THE NATIVE MITRAL ANNULUS REMAINED ATTACHED TO THE SEWING RING WITH SEVERAL PLEDGETS INTACT ADJACENT TO THE RIGHT CUSP ON THE OUTFLOW. ALL LEAFLETS WERE INTACT. FRIABLE TISSUE, CONSISTENT WITH POST-MORTEM CLOTTING WAS NOTED ON THE INFLOW OF ALL CUSPS. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THE CAUSE OF DEATH WAS ATTRIBUTED TO MYOCARDIAL INFARCTION. THE PHYSICIAN DID NOT FEEL THE DEATH WAS RELATED TO THE VALVE, AND THERE WERE NO ALLEGATIONS AGAINST THE VALVE OR ITS FUNCTION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THE PT IMPLANTED WITH THE BIOPROSTHETIC VALVE, IMPLANTED 3 DAYS, DIED DUE TO A MYOCARDIAL INFARCTION (MI). IT WAS REPORTED THAT DOCTOR DID NOT FEEL THIS WAS A VALVE RELATED DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE LWR MEDTRONIC HEART VALVES, INC. T510 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death