BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2133318 · Received June 20, 2011

    Report

    Report Number
    2134265-2011-02293
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    April 5, 2011
    Report Date
    May 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    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. (B)(4). THE TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS RECEIVED IN THE HOOP AND THE PRODUCT POUCH WITH ACCESSORY KIT. THERE WAS CONTRAST IN THE WIRE LUMEN. THE BALLOON WAS TIGHTLY FOLDED. THE FIRST THREE ROWS ON THE DISTAL END OF THE STENT WERE DAMAGED AND STRETCHED. THE REPORTED DIFFICULTY CROSSING LESION IS CONSISTENT WITH THE DISTAL STENT DAMAGE. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. 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, STENT WOULD NOT CROSS THE LESION. VASCULAR ACCESS WAS GAINED VIA THE FEMORAL ARTERY. THE 85% STENOSED, 2.25X21MM LESION BEING TREATED WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD). PHYSICIAN ATTEMPTED TO CROSS LESION WITH A 2.25X24MM TAXUS LIBERTE AND WAS NOT SUCCESSFUL. PHYSICIAN RE-DILATED THE LESION AND ATTEMPTED TO CROSS WITH ANOTHER OF THE SAME DEVICE BUT AGAIN COULD NOT CROSS THE LESION. PHYSICIAN DECIDED TO END THE PROCEDURE. 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 - MAPLE GROVE H7493894024220 13680495

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR