BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMUS GPS BILIARY STENT

    MDR report key: 618286 · Received June 28, 2005

    Report

    Report Number
    2183780-2005-00025
    Event Type
    Injury
    Date Received
    June 28, 2005
    Date of Event
    May 17, 2005
    Report Date
    May 21, 2005
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PRIMUS STENT WAS PLACED OVER AN .035 WIRE DISTAL TO THE STENOSIS. WHEN PHYSICIAN ATTEMPTED TO PULL BACK ON THE BALLOON TO REALIGN THE BALLOON/STENT WITH THE STENOSIS, THE STENT BECAME DETACHED FROM THE BALLOON AND FLOATED DOWNSTREAM. THE BALLOON WAS NOT INFLATED AT ANY POINT BUT THE STENT CAME LOOSE ANYHOW. THE PHYSICIAN THEN CHOSE A COMPETITIVE BSC DEVICE AND INFLATED WITH A NICE RESULT. HE THEN USED A GOOSE NECK SNARE TO RETRIEVE THE LOOSE PRIMUS STENT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMUS GPS BILIARY STENT STENT FGE EV3 INC. BXB35-06-12-75 844671

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention