BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1083393 · Received July 28, 2008

    Report

    Report Number
    2134265-2008-02112
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    May 21, 2008
    Report Date
    June 30, 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

    THE DEVICE WAS RETURNED TO FOR ANALYSIS AND INITIAL VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED DISTAL STENT DAMAGE. SOME OF THE STRUTS WERE MISALIGNED. THE DAMAGE FOUND ON THE STENT WAS MEASURED USING A SNAP GAUGE AT APPROXIMATELY 1.25MM. THE AREA WHERE THERE WAS NO DAMAGE FOUND WAS MEASURED AT APPROXIMATELY 1.19MM. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE DEVICE MEETING SOME FORM OF RESTRICTION DURING THE INSERTION OF THE DEVICE. NO KINKS OR DAMAGE WAS FOUND ON 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. AS THE COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS DESIGN AND MANUFACTURE SPECIFICATION, BUT DUE TO THE LIKELIHOOD THAT THE PATIENT ANATOMY OR OTHER PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE PERFORMANCE WAS LIMITED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO CROSS THE LESION. ANALYSIS WAS COMPLETED AND STENT DAMAGE WAS FOUND. THIS COMPLAINT IS NOW REPORTABLE BASED ON ANALYSIS COMPLETED ON 06/30/2008. THE LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA) ATRIOVENTRICULAR BRANCH. IT WAS 90% STENOSED WITH SEVERE CALCIFICATION AND SEVERE TORTUOUSITY. THE LESION WAS PRE-DILATED AND PRE-IVUS WAS PERFORMED. THE PHYSICIAN DIAGNOSED THE MINIMUM LUMEN DIAMETER WAS 2.5MM. HE ATTEMPTED TO ADVANCE TAXUS EXPRESS2 2.5X16MM STENT TO THE LESION. BUT THE STENT WAS UNABLE TO CROSS PROXIMAL LOCATION OF THE TARGET LESION. THEREFORE, HE REMOVED THE STENT AND DILATED THE LESION. THE PHYSICIAN TRIED TO IMPLANT THE TAXUS STENT IN THE LESION AGAIN. BUT THE STENT WAS NOT ABLE TO CROSS THE PROXIMAL LOCATION OF THE TARGET LESION. AND THEN, THE PHYSICIAN TRIED TO IMPLANT TWO NON BSC 2.5X16MM STENTS, BUT THESE STENTS WERE NOT ABLE TO CROSS TO THE SAME LOCATION. THE PROCEDURE WAS COMPLETED WITH IMPLANT OF NON BSC 2.25MM STENT. THE PATIENT STATUS IS LISTED AS GOOD. THE TAXUS STENT WAS RETURNED AND STENT DAMAGE WAS DISCOVERED DURING PRODUCT ANALYSIS.

    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 2.50MMX16MM 11286259

    Patients

    Seq Age Sex Outcome Treatment
    1