BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2170475 · Received July 21, 2011

    Report

    Report Number
    2134265-2011-02727
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT THE TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A TAXUS LIBERTE MONORAIL (MR) STENT DELIVERY SYSTEM (SDS) IN TWO PIECES. BLOOD AND CONTRAST WERE IN THE DISTAL AND MIDSHAFT OF THE DEVICE WHICH IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE DEVICE WAS USED. IT WAS DETERMINED THAT THE HYPOTUBE WAS BROKEN 17CM DISTALLY FROM THE STRAIN RELIEF. MICROSCOPIC EXAMINATION OF THE MATERIAL SURROUNDING THE HYPOTUBE BREAK DID NOT REVEAL ANY INHERENT DEFICIENCIES THAT WOULD HAVE CONTRIBUTED TO THE INCIDENT. ANALYSIS OF THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) A SHAFT KINK OCCURRED. THE 80% STENOSED LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS RIGHT POSTERIOR DESCENDING ARTERY. THE LESION WAS PREDILATED USING A 2.0X20MM APEX BALLOON. THE 2.25X24MM TAXUS LIBERTE ATOM WAS ADVANCED, BUT THE STENT DID NOT CROSS THE LESION. THE STENT DELIVERY SYSTEM WAS REMOVED AND THE LESION WAS PRE-DILATED AGAIN WITH AN APEX 2.0X20 BALLOON. THE STENT DELIVERY SYSTEM WAS REINSERTED AND THE SHAFT KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED COMPLICATIONS. THE PATIENT'S STATUS IS FINE. HOWEVER, DEVICE ANALYSIS REVEALED A SHAFT FRACTURE.

    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 H7493893624220 0014055375

    Patients

    Seq Age Sex Outcome Treatment
    1