BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT

    MDR report key: 1063063 · Received June 17, 2008

    Report

    Report Number
    2183870-2008-00077
    Event Type
    Other
    Date Received
    June 17, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 21, 2008
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN HAD PUT A LOT OF BACK PRESSURE ON THE STENT TO GET IT TO DEPLOY. THAT RESULTED IN THE STENT ELONGATING AROUND 15%. THEY FINISHED THE CASE BY PLACING A SECOND STENT THAT WAS GOING TO BE PLACED EITHER WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT FGE EV3 INC. PRB35-06-150-120 4901311

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other