BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1060063 · Received June 11, 2008

    Report

    Report Number
    2134265-2008-01653
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, WITHDRAWAL DIFFICULTY AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE 90% STENOTIC AND SEVERELY TORTUOUS AND CALCIFIED LEFT CIRCUMFLEX (LCX). THE PHYSICIAN PREDILATED THE LESION USING AN APEX BALLOON (SIZE UNK). THE PHYSICIAN THEN ATTEMPTED TO DELIVER THE 3.00 X 24 MM TAXUS EXPRESS2 DRUG ELUTING STENT, BUT WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN ATTEMPTED TO REMOVE THE TAXUS STENT IN ORDER TO PERFORM PLAIN OLD BALLOON ANGIOPLASTY AND RESISTANCE WAS FELT. THE STENT DELIVERY SYSTEM (SDS) WAS PUSHED TO BIAS THE DEVICE, BUT IT WAS UNABLE TO BE REMOVED. AFTER THAT, THE SDS WAS PULLED BACK WITH EXCESSIVE FORCE AND WAS REMOVED SUCCESSFULLY. IT WAS NOTED THAT THE PROXIMAL EDGE OF THE STENT WAS LIFTED. THE PHYSICIAN FELT THAT THE STENT MAY HAVE CAUGHT ON THE SEVERE CALCIFICATION IN THE LESION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE, AND THERE WERE NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 3.00 X 24 MM 11341361

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR GUIDE CATHETER: LAUNCHER| SHEAT: TERUMO| GUIDE WIRE: FIELDER