BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRASTENT DOUBLESTRUT PARAMOUNT XS

    MDR report key: 593750 · Received June 9, 2004

    Report

    Report Number
    2134479-2004-00007
    Event Type
    Malfunction
    Date Received
    June 9, 2004
    Date of Event
    April 15, 2004
    Report Date
    June 7, 2004
    Manufacturer
    EV3 INC
    Product Code
    NIN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS TRYING TO PLACE A SPM14-12-06B PARAMOUNT XS IN A RIGHT RENAL ARTERY THROUGH A 8FR GUIDE OVER A .018 WIRE, STENT DISLODGED. THE STENT WAS RETREIVED USING A SNARE. THE PHYSICIAN FINISHED THE CASE USING A GUIDANT HERCULINKSTENT. THE PATIENT SUFFERED NO ILL EFFECTS FROM THIS INCIDENT. THE DEVICE WAS DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRASTENT DOUBLESTRUT PARAMOUNT XS STENT NIN EV3 INC SPM14-12-06B 363431

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention