BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1002069 · Received February 20, 2008

    Report

    Report Number
    2134265-2008-00495
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Report Date
    February 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE DEVICE WAS RETURNED INSERTED IN THE GUIDE CATHETER. VISUAL AND MICROSCOPIC EXAMINATION OF THE STENT REVEALED PROXIMAL STENT DAMAGE. SOME OF THE STRUTS WERE BENT BACK DISTALLY. THE DAMAGE FOUND ON THE STENT WAS MEASURED USING A SNAP GAUGE AT 1.62MM. THE AREA WHERE THERE WAS NO DAMAGE FOUND ON THE STENT WAS MEASURED AT 1.18MM. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE MOST PROBABLE ROOT CAUSE OF THIS DEFECT WILL BE DOCUMENTED AS OPERATIONAL CONTEXT DUE TO THE LIKELIHOOD THAT THE PT ANATOMY OR OTHER PROCEDURAL FACTORS CONTRIBUTED TO THE REPORTED DIFFICULTY.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED IN 2008. IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE, BALLOON INFLATION DIFFICULTIES OCCURRED. A 3.0X16MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) HAD BEEN CROSSED TO TREAT AN UNSPECIFIED TARGET LESION. THE "BALLOON WOULD NOT INFLATE, AND THE STENT WOULD NOT DEPLOY." THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.0X16MM TAXUS EXPRESS2 DES. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "OK." HOWEVER, THE RETURNED PRODUCT CONFIRMED THERE WAS STENT DAMAGE.

    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 3.0X16MM 11072504

    Patients

    Seq Age Sex Outcome Treatment
    1