BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1002075 · Received February 20, 2008

    Report

    Report Number
    6000089-2008-00014
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    December 18, 2007
    Report Date
    February 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING A DETAILED DEVICE ANALYSIS, IT WAS NOTED THAT THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT REPORTED. THE DEVICE WAS RETURNED IN TWO SECTIONS FOR ANALYSIS, AS A RESULT OF A BREAK THAT OCCURRED IN THE HYPOTUBE. THE BREAK WAS MEASURED AT APPROX 25CM DISTAL FROM THE STRAIN RELIEF. SEVERAL SEVERE KINKS WERE FOUND ALONG THE ENTIRE LENGTH OF THE HYPOTUBE. VISUAL AND MICROSCOPIC EXAMINATION OF THE STENT REVEALED PROXIMAL AND DISTAL STENT DAMAGE. THE STRUTS ON THE PROXIMAL END WERE SEVERELY MISALIGNED. THE DAMAGE FOUND ON THE STENT WAS MEASURED AT 1.82MM USING A SNAP GAUGE. THE AREA WHERE THERE WAS NO DAMAGE FOUND ON THE STENT WAS MEASURED AT 1.22MM. PROXIMAL STENT DAMAGE IS CONSISTENT WITH THE DEVICE MEETING SOME FORM OF RESTRICTION DURING THE WITHDRAWAL OF THE DEVICE. SOME OF THE DISTAL STRUTS WERE RAISED. THE DAMAGED WAS MEASURED AT 1.91MM. DISTAL STENT DAMAGE IS CONSISTENT WITH THE DEVICE MEETING SOME FORM OF RESTRICTION DURING THE INSERTION OF THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A CAPA HAS NOT BEEN INITIATED TO ADDRESS THIS ISSUE. 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 ON 02/14/2008. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE 2.75X32 MM TAXUS EXPRESS2 DRUG ELUTING STENT COULD NOT BE ADVANCED THROUGH THE GUIDE CATHETER AND THE SHAFT KINKED. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE CALCIFIED, EXTREMELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PT COMPLICATIONS WERE REPORTED. PT STATUS REPORTED AS "GOOD." HOWEVER, THE RETURNED PRODUCT REVEALED STENT DAMAGE AND A SHAFT FRACTURE.

    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 2.75X32 MM 11022560

    Patients

    Seq Age Sex Outcome Treatment
    1