BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1023837 · Received April 2, 2008

    Report

    Report Number
    6000089-2008-00025
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    January 25, 2008
    Report Date
    March 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING A DETAILED DEVICE ANALYSIS, IT WAS NOTED THAT THE CONDITION OF THE RETURNED UNIT WAS NOT CONSISTENT WITH THE COMPLAINT INCIDENT. THE DEVICE WAS RETURNED FOR ANALYSIS AND INITIAL VISUAL EXAMINATION OF THE RETURNED UNIT FOUND THAT THE TIP WAS DAMAGED AND THAT THE STENT HAD MOVED ON THE DEVICE. THE STENT ITSELF HAD MIGRATED 5MM PROXIMALLY AND PARTIALLY COVERED THE PROXIMAL MARKER BAND. KINKS WERE PRESENT ALONG THE ENTIRE LENGTH OF THE HYPOTUBE. THE STENT MIGRATION DAMAGE IS CONSISTENT WITH THE DEVICE ENCOUNTERING SOME FORM OF RESTRICTION ON WITHDRAWAL. THE TIP DAMAGE IS CONSISTENT WITH THE UNSUCCESSFUL ATTEMPTS WHEN LOADING THE GUIDE WIRE. THE HYPOTUBE KINK DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. ATTEMPTS TO INSERT THE RECOMMENDED SIZE GUIDE WIRE PAST THE TIP WERE UNSUCCESSFUL DUE TO DAMAGE AT THE TIP. ATTEMPTS TO INSERT THE RECOMMENDED SIZE GUIDE WIRE FROM THE PORT REGION WERE UNSUCCESSFUL DUE TO SOLIDIFIED CONTRAST MEDIA PRESENT WITHIN THE ENTIRE LENGTH OF THE LUMEN. THE BALLOON SECTION OF THE DEVICE WAS VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH ITS PROFILE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. A REVIEW OF THE TOP ASSEMBLY DEVICE HISTORY RECORD FOR THIS PARTICULAR BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. BASED ON THIS ANALYSIS, THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT CAN BE ATTRIBUTED TO OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON 03/28/2008. IT WAS REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE 3.00X12MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) WOULD NOT ADVANCE OVER THE GUIDE WIRE. NO PT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED PRODUCT ANALYSIS REVEALED THAT THE TIP WAS DAMAGED, THE STENT HAD MOVED ON THE DEVICE AND KINKS WERE PRESENT ALONG THE ENTIRE LENGTH OF THE HYPOTUBE.

    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 3.00X12MM 9705664

    Patients

    Seq Age Sex Outcome Treatment
    1