BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTEGE GPS SELF EXPANDING NITINOL STENT

    MDR report key: 1546770 · Received November 25, 2009

    Report

    Report Number
    2183870-2009-00162
    Event Type
    Other
    Date Received
    November 25, 2009
    Date of Event
    October 30, 2009
    Report Date
    October 30, 2009
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PROTEGE STENT WAS INITIALLY DEPLOYED WITHOUT INCIDENT IN THE RIGHT COMMON ILIAC. UPON POST-DILATION, THE STENT MIGRATED DISTALLY. NO FURTHER INTERVENTION WAS REQUIRED. NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE GPS SELF EXPANDING NITINOL STENT FGE EV3 INC. SERP65-10-40-80 7524843

    Patients

    Seq Age Sex Outcome Treatment
    1 98 YR Required Intervention