BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEGE EVERFLEX 7X40 MM

    MDR report key: 976518 · Received November 20, 2007

    Report

    Report Number
    976518
    Event Type
    Malfunction
    Date Received
    November 20, 2007
    Date of Event
    November 2, 2007
    Report Date
    November 20, 2007
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN AND RESIDENT WERE TRYING TO PUT THE STENT DELIVERY IN 6 FR. SHEATH AND IT DIDN'T GO IN. THE STENT DEPLOYED ON THE WIRE WHEN THE DOCTOR WAS TRYING TO REMOVED THE DEVICE (THE DEVICE DEPLOYED WITHOUT THE SAFETY VALVE BEING RELEASED). MANUFACTURER RESPONSE FOR STENT,VASCULAR, PROTEGE EVERFLEX 7X40 MM:THEY HAVE REQUESTED THE DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE EVERFLEX 7X40 MM STENT, VASCULAR FGE EV3 INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR