BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT-UNI ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    MDR report key: 1221530 · Received November 5, 2008

    Report

    Report Number
    2134265-2008-04202
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    September 24, 2008
    Report Date
    October 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIO
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS MFG: 2134265-2008-04216. IT WAS REPORTED THAT DURING AN DEEP VEIN THROMBOSIS (DVT) STENTING PROCEDURE, A GUIDE WIRE COULD NOT BE REMOVED FROM A STENT. THE VASCULAR ACCESS SITE WAS THE POPLITEAL VEIN. THE LESION WAS LOCATED IN THE NON TORTUOUS COMMON ILIAC VEIN. THE LESION WAS 80% STENOSED AND NOT CALCIFIED. INSIDE THE PT, AN AMPLATZ 0.035INCH X 180CM GUIDE WIRE COULD NOT BE REMOVED FROM THE WALLSTENT 12 X 90CM X 100CM. THE GUIDE WIRE AND THE STENT WERE REMOVED TOGETHER FROM THE PT. THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT FROM THE GUIDE WIRE WITH FORCE OUTSIDE THE PT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER WALLSTENT 12 X 90MM X 100CM AND ANOTHER AMPLATZ 0.035INCH X 180CM GUIDE WIRE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PT'S STATUS IS REPORTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT-UNI ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM NA NIO BOSTON SCIENTIFIC NA 11700009

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR