BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1234048 · Received November 4, 2008

    Report

    Report Number
    2134265-2008-04208
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 7, 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

    A REVIEW OF THE MANUFACTURING DOCUMENTATION FOUND THAT THE DEVICE MET ITS MATERIAL ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE DEVICE WAS RETURNED FOR ANALYSIS AND VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED DISTAL STENT DAMAGE. SOME OF THE STRUTS WERE MISALIGNED. THE OUTER DIAMETER (OD) OF THE DAMAGE FOUND ON THE STENT WAS MEASURED USING A SNAP GAUGE AT APPROXIMATELY 1.29MM. THE OD OF THE AREA WHERE THERE WAS NO DAMAGE FOUND WAS MEASURED AT APPROXIMATELY 1.2MM. NO KINKS OR DAMAGE WAS FOUND ALONG THE HYPOTUBE. 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 0.015 INCH PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. THIS INVESTIGATION WILL BE ASSIGNED THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE STENT WAS DAMAGED. THE LESION BEING TREATED WAS 90% STENOSED WITH CALCIFICATION IN AN EXTREMELY TORTUOUS PORTION OF THE LEFT ANTERIOR DESCENDING (LAD), WITH IN-STENT RESTENOSIS. THE PHYSICIAN TRIED TO CROSS THE LESION, BUT THE PROXIMAL EDGE COULDN'T BE CROSSED. IT WAS NOTICED WHEN IT WAS REMOVED THAT THE STENT WAS LIFTED UP. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER DEVICE. THERE WERE NO COMPLICATIONS AND THE PT 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 BOSTON SCIENTIFIC 2.75X16MM 11678741

    Patients

    Seq Age Sex Outcome Treatment
    1