BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EV3

    MDR report key: 1063114 · Received June 19, 2008

    Report

    Report Number
    MW5007365
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 10, 2008
    Manufacturer
    EV3
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN ATTEMPTING TO DEPLOY A STENT IN THE LEFT FEMORAL ARTERY. STENT FRACTURED AND PART BECAME LODGED AT THE DISTAL END OF PREVIOUSLY PLACED STENT WHILE OTHER PART LODGED IN FEMORAL ARTERY. UNABLE TO REMOVE STENT WITH SNARE. SENT TO OR FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EV3 STENT FGE EV3

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| O| R