BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTEGE RX CAROTID

    MDR report key: 1014101 · Received March 7, 2008

    Report

    Report Number
    2183870-2008-00025
    Event Type
    Other
    Date Received
    March 7, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 14, 2008
    Manufacturer
    EV3 INC.
    Product Code
    NIM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED IN THE SFA: PHYSICIAN HAD TO FORCE THE CATHETER TO DEPLOY WHICH CAUSED HANDLE SEPARATION. THE STENT WAS THEN DEPLOYED ELONGATED AND NOT DEPLOYED IN THE TARGET AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE RX CAROTID NIM NIM EV3 INC. PRB35-06-150-120 4999793

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other