BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2170588 · Received July 21, 2011

    Report

    Report Number
    2134265-2011-02905
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    April 26, 2011
    Report Date
    June 30, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED DISTAL AND PROXIMAL STENT DAMAGE. A NUMBER OF STRUT ROWS WERE RAISED AND MISALIGNED AT BOTH ENDS. THE TIP WAS DAMAGED. THE BALLOON SECTION OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH IT'S PROFILE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. SOLIDIFIED BLOOD WAS WITHIN THE LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. A MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON THE ANALYSIS COMPLETED (B)(6) 2011 IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, THE 2.25X24 MM TAXUS LIBERTE STENT WOULD NOT CROSS A PREVIOUSLY PLACED NON-BSC STENT. VASCULAR ACCESS WAS GAINED VIA THE FEMORAL ARTERY. THE PROGRESSIVE 2.0-2.25X22MM LESION BEING TREATED WAS LOCATED IN THE 80% STENOSED MILDLY TORTUOUS AND NON-CALCIFIED OBTUSE MARGINAL (OM) ARTERY. A NON-BSC GUIDE CATHETER AND A CHOICE PT AND NON-BSC GUIDE WIRES WERE ADVANCED AND THE LESION WAS PRE-DILATED WITH A 2.0X20MM BALLOON. THE PHYSICIAN ATTEMPTED TO CROSS THE LESION WITH THE TAXUS LIBERTE STENT AND WAS NOT ABLE TO CROSS A PREVIOUSLY PLACED STENT IN THE LEFT CIRCUMFLEX (LCX) ARTERY. THE STENT SYSTEM WAS REMOVED FROM THE PATENT AND THE PROCEDURE WAS COMPLETED WITHOUT A STENT DEPLOYMENT. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS STABLE. RETURNED PRODUCT ANALYSIS REVELED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894024220 13760039

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR