BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 2190315 · Received July 20, 2011

    Report

    Report Number
    2025587-2011-00089
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 21, 2011
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHOD: DEVICE HISTORY COULD NOT BE REVIEWED AS NO SERIAL NUMBER WAS PROVIDED. RESULTS: NO PRODUCT WAS RETURNED. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. SHOULD THE PRODUCT BE RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS BIOPROSTHETIC VALVE WAS ABANDONED AFTER IMPLANT. IT WAS REPORTED THAT THE OPENING AND CLOSING OF THE VALVE WAS NOT SMOOTH AND THE DOCTOR WAS CONCERNED IT MAY LEAK IN THE FUTURE. THE VALVE WAS SUCCESSFULLY REPLACED WITH ANOTHER BIOPROSTHETIC VALVE. THERE WERE NO ADVERSE PT EFFECTS REPORTED.

    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 Required Intervention