BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE BILIARY SELF-EXPENDING STENT SYSTEM

    MDR report key: 2028390 · Received March 18, 2011

    Report

    Report Number
    MW5019890
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 18, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STENT PREMATURELY OPENED PRIOR TO DEPLOYMENT. MEDTRONIC STENT 5MM X 20MM X 130 CM, REF (B)(4); LOT # 0005161035; EXP DATE 11/22/2012. PHYSICIAN WAS PLACING STENT OVER WIRE TO LOCATION, DEVICE IS LOCKED. UPON COMPLETION OF LOCATION, NOTED STENT WAS MUSHROOMING OPEN ON END OF STENT AND NOT ALLOWING HIM TO PLACE STENT AT PROPER LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE SE BILIARY SELF-EXPENDING STENT SYSTEM MEDTRONIC SE BILIARY STENT FGE MEDTRONIC, INC. 5MM X 20MM X 130CM 0005161035

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR