BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1220282 · Received November 3, 2008

    Report

    Report Number
    2134265-2008-04173
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 9, 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, STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS, NON CALCIFIED DISTAL LEFT CIRCUMFLEX (LCX). AN UNK SIZE STENT WAS IMPLANTED IN THE OSTIUM OF THE LCX AND THEN THE LESION WAS PREDILATED WITH AN UNSPECIFIED DEVICE. THE 2.50X16MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) WAS THEN ADVANCED TO THE TARGET LESION BUT THE DEVICE WAS UNABLE TO CROSS THE PREVIOUSLY PLACED STENT. THE PHYSICIAN THEN ATTEMPTED TO USE THE 5 IN 6 APPROACH WHERE A 5FR GUIDING CATHETER IS INSERTED IN 6FR GUIDING CATHETER. THE 5FR GUIDING CATHETER WAS USED AS AN ANCHOR AND THEN THE TAXUS EXPRESS2 DEVICE WAS INSERTED IN THE 5FR CATHETER. THIS ATTEMPT WAS ALSO UNSUCCESSFUL. THE TAXUS EXPRESS2 DES WAS REMOVED FROM THE PT AND IT WAS NOTICED THAT THE STENT WAS FLARED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITH NO PT COMPLICATIONS REPORTED. THE PT'S CURRENT CONDITION IS LISTED AS "GOOD".

    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 2.50X16MM 11785947

    Patients

    Seq Age Sex Outcome Treatment
    1