BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEGE STENT

    MDR report key: 596746 · Received June 18, 2004

    Report

    Report Number
    2134479-2004-00009
    Event Type
    Malfunction
    Date Received
    June 18, 2004
    Date of Event
    May 10, 2004
    Report Date
    June 17, 2004
    Manufacturer
    EV3 INC
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRE DILATED WITH 5MM BALLOON, WENT IN WITH THE STENT AND DEPLOYED ABOUT A FOURTH OF THE STENT AND IT DEPLOYED PERFECTLY, BUT THEN IT STOPPED DEPLOYING AND THEN IT CEASED TO DEPLOY. THE PHYSICIAN PULLED ON THE DELIVERY CATHETER AND TRIED TO GET IT TO DEPLOY AND IT SNAPPED. THE STENT BECAME ELONGATED. THE PHYSICIAN THEN POST DILATED THE REMAINDER OF THE STENT AND DEPLOYED. FLOW WAS RE-ESTABLISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE STENT STENT FGE EV3 INC SE7-7-150-120 141422

    Patients

    Seq Age Sex Outcome Treatment
    1 *