BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTEGE STENT

    MDR report key: 709415 · Received May 5, 2006

    Report

    Report Number
    2183870-2006-00016
    Event Type
    Other
    Date Received
    May 5, 2006
    Date of Event
    March 24, 2006
    Report Date
    April 6, 2006
    Manufacturer
    *
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PROTEGE STENT WAS PLACED ACROSS IN THE SFA AND THE STENT WOULD NOT DEPLOY. A DISSECTION AND THROMBUS IN THE LEFT SFA WAS NOTED DURING THE MANIPULATION OF THE WIRE AND STENT DELIVERY SYSTEM WHEN TRYING TO DEPLOY THE STENT. IT IS REPORTED THAT THERE WAS PRESSURE APPLIED WHILE TRYING TO PUL BACK THE STENT DELIVERY SYSTEM. THE STENT WITH GUIDEWIRE AND DELIVERY SYSTEM WAS PULLED OUT OF THE PATIENT'S BODY. AFTER OBSERVING THE PATIENT NO INTERVENTION PERFORMED AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE STENT FGE FGE * SERP65-06-150-120 1145388

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other