BEUDAMED
    FDA Adverse Event Summary report: N

    TAXUS

    MDR report key: 1113103 · Received August 1, 2008

    Report

    Report Number
    1113103
    Date Received
    August 1, 2008
    Date of Event
    June 2, 2008
    Report Date
    July 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC, INC.
    Product Code
    NIQ
    Report Source
    User Facility report
    Reporter Location
    AR, US

    Narratives

    Description of Event or Problem · 1

    A TAXUS STENT 2.75 X 20 MM WAS INSERTED INTO THE SAPHENOUS VEIN GRAFT LESION (OBTUSE MARGINAL) AND INITIALLY WOULD NOT CROSS. A PTCA BALLOON WAS INSERTED AND DILATED THE VESSEL. ATTEMPTED TO INSERT TAXUS STENT, BUT STILL WOULD NOT CROSS. WHEN REMOVING TAXUS STENT, IT SLIPPED FREE FROM THE BALLOON LYING IN THE PROXIMAL SAPHENOUS VEIN GRAFT. PHYSICIAN HAD TO "PANCAKE" STENT AGAINST THE SAPHENOUS VEIN GRAFT WALL AND DEPLOY NEW STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS STENT, DRUG-ELUTING NIQ BOSTON SCIENTIFIC, INC. * 11124383

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR