BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTEGRA PULMONARY VALVED CONDUIT

    MDR report key: 1729576 · Received June 16, 2010

    Report

    Report Number
    2025587-2010-00051
    Event Type
    Death
    Date Received
    June 16, 2010
    Report Date
    May 17, 2010
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVAL: 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 FOR ANALYSIS. CONCLUSION: THE CAUSE OF DEATH IS UNK AT THIS TIME, HOWEVER, IT WAS REPORTED THAT IT WAS NOT RELATED TO THE DEVICE. ADDITIONAL INFO WAS REQUESTED, BUT WAS NOT RECEIVED. SHOULD ADDITIONAL INFO BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THE PT WITH THIS BIOPROSTHETIC VALVED CONDUIT DIED THE SAME DAY AS RE-OPERATION. IT WAS REPORTED THAT THE PT HAD PREVIOUSLY UNDERGONE A ROSS PROCEDURE WHERE A BIOPROSTHETIC PULMONARY VALVED CONDUIT WAS PLACED IN THE PULMONARY POSITION. THE PULMONARY VALVED CONDUIT REPORTEDLY HAD CALCIFIED DUE TO AN ANEURYSM ON THE AORTA WHICH HAD BULGED INTO THE PULMONARY VALVED CONDUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTEGRA PULMONARY VALVED CONDUIT MWH MEDTRONIC HEART VALVES, INC. 200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death