BEUDAMED
    FDA Adverse Event Death Summary report: N

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1746163 · Received June 28, 2010

    Report

    Report Number
    2025587-2010-00064
    Event Type
    Death
    Date Received
    June 28, 2010
    Report Date
    June 3, 2010
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION 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 MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. ATTEMPTS TO RECEIVE ADDITIONAL INFORMATION WERE UNSUCCESSFUL. IT IS UNKNOWN IF THE CAUSE OF DEATH IS RELATED TO THE VALVE OR THE PROCEDURE.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE PROCEDURE, THE SINOTUBULAR JUNCTION WAS TORN. IT WAS REPORTED THAT THE 23 MM SIZER PASSED FINE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DIED. THE TIMING OF THE DEATH IN RELATION TO THE PROCEDURE AND CAUSE OF THE DEATH IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED FROM THE PHYSICIAN WITHOUT RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE LWR MEDTRONIC HEART VALVES, INC. T505 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death