BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1063804 · Received June 18, 2008

    Report

    Report Number
    2134265-2008-01710
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    April 25, 2008
    Report Date
    June 17, 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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE STENT HAVE MOVED SLIGHTLY ON THE BALLOON TOWARDS THE TIP OF THE DEVICE. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE DEVICE ENCOUNTERING SOME FORM OF RESTRICTION DURING THE INSERTION OF THE DEVICE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE CRIMPED STENT FOUND NO ISSUES. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO ANY POSITIVE PRESSURE. A 0.014 INCH PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTION NOTED. A REVIEW OF THE MFG RECORD FOR THIS PARTICULAR BATCH SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THIS DEFECT IS DETERMINED TO BE OPERATIONAL CONTEXT DUE TO THE ANATOMICAL AND/OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    THIS EVENT IS REPORTABLE BASED ON THE PRODUCT ANALYSIS APPROVED ON 06/17/2008. IT WAS REPORTED THAT DURING A DRUG ELUTING STENTING PROCEDURE, THE PHYSICIAN WAS UNABLE TO CROSS THE LESION LOCATED IN THE MODERATELY TORTUOUS AND HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ADVANCED THE 3.50X12MM TAXUS EXPRESS2 STENT TO THE LESION AND ATTEMPTS TO CROSS WERE MADE OVER AND OVER, BUT THE DEVICE WAS UNABLE TO CROSS THE LESION. THERE WERE NO PT INJURIES. THE PROCEDURE WAS COMPLETED WITH A NON-BSC STENT. PATIENT STATUS IS REPORTED AS "GOOD". HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED THAT THE STENT MOVED ON THE BALLOON.

    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 3.50X12MM 11085685

    Patients

    Seq Age Sex Outcome Treatment
    1 DRIVER STENT