BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1102125 · Received August 7, 2008

    Report

    Report Number
    2134265-2008-02243
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 31, 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 EVAL: A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE PROXIMAL EDGE OF THE STENT WAS DAMAGED. THE STRUTS ON THE FIRST PROXIMAL STENT ROW WERE SLIGHTLY RAISED. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE DELIVERY SYSTEM ENCOUNTERING SOME FORM OF RESTRICTION. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. A RECOMMENDED SIZED PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. 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. SOLIDIFIED BLOOD WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE, INDICATING THE DEVICE HAD BEEN USED IN VIVO. A REVIEW OF THE MANUFACTURING RECORD FOR THIS PARTICULAR BATCH SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED DIFFICULTY 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 IN 2008. IT WAS REPORTED THAT DURING A DRUG ELUTING STENTING TREATMENT PROCEDURE THE PHYSICIAN WAS UNABLE TO CROSS THE LESION. THE 100% STENOTIC LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS MID RIGHT CORONARY ARTERY. THE PHYSICIAN ADVANCED THE 3.50X12MM TAXUS EXPRESS2 STENT TO THE LESION, BUT WAS UNABLE TO CROSS. HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED THAT THERE WAS STENT DAMAGE.

    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 H7493897012350 0011046785

    Patients

    Seq Age Sex Outcome Treatment
    1