BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1171326 · Received September 17, 2008

    Report

    Report Number
    2134265-2008-02652
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE STENT WAS NOT WELL APPOSED AND REQUIRED ADDITIONAL DILATION. THE LESION BEING TREATED WAS 90% STENOTIC, CALCIFIED, AND MODERATELY TORTUOUS. IT WAS LOCATED IN THE DISTAL PORTION OF THE MID LEFT ANTERIOR DESCENDING (LAD). WITHOUT PREDILATING THE LESION, THE PHYSICIAN DELIVERED THE 2.5X20MM TAXUS EXPRESS2 DRUG ELUTING STENT TO THE LESION AND DEPLOYED IT AT 12 ATMS. THE PROXIMAL PORTION OF THE STENT WAS NOT WELL APPOSED BECAUSE THE PROXIMAL PORTION OF THE TARGET LESION WAS LARGER. THE PHYSICIAN MOVED THE STENT DELIVERY BALLOON TO THE PROXIMAL PORTION, AND INFLATED THE BALLOON TO ABOUT 14 ATMS. HOWEVER, THE STENT WAS STILL NOT WELL APPOSED. THE PHYSICIAN THEN DELIVERED A NON-BSC 2.75X20MM BALLOON AND POST-DILATED THE STENT. THE PHYSICIAN FELT THAT THE STENT WAS LONGER THAN 20MM. USING IVUS, THE PHYSICIAN MEASURE THE IMPLANTED STENT LENGTH TO BE 24MM. THE PROCEDURE WAS THEN COMPLETED AND THE PATIENT CONDITION IS REPORTED 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 CORPORATION 2.50X20MM 11456813

    Patients

    Seq Age Sex Outcome Treatment
    1 NC MERCURY BALLOON