BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2172765 · Received July 22, 2011

    Report

    Report Number
    2134265-2011-02981
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    April 22, 2011
    Report Date
    June 23, 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 COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE IDENTIFIED STENT DAMAGE. STRUTS TOWARDS THE PROXIMAL END OF THE STENT WERE MISALIGNED. THE OUTER DIAMETER (OD) OF THE DAMAGED SECTION WAS MEASURED AT 1.42 MM. THE OD OF THE STENT AREA WHERE NO DAMAGE WAS PRESENT WAS MEASURED AT 1.05 MM. THE TIP WAS SLIGHTLY FLARED. NO ISSUES WERE NOTED WITH THE BALLOON SECTION OF THE DEVICE. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. THERE WAS A KINK IN THE LUMEN 155 MM PROXIMAL TO THE TIP. THERE WAS ALSO A KINK IDENTIFIED IN THE HYPOTUBE 40 MM DISTAL TO THE CATHETER'S STRAIN RELIEF. SOLIDIFIED BLOOD WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN. ATTEMPTS TO INSERT A 0.015 INCH PRODUCT MANDREL WERE UNSUCCESSFUL DUE TO SOLIDIFIED BLOOD PRESENT WITHIN THE ENTIRE LENGTH OF THE LUMEN. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS USE ERROR. HEAVILY CALCIFIED LESIONS AND HIGHLY TORTUOUS ANATOMIES ARE CONTRAINDICATED IN THE DFU. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT COULD NOT CROSS THE LESION. THE LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE 32 X 2.25MM TAXUS LIBERTE MONORAIL STENT DELIVERY SYSTEM COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, PRODUCT ANALYSIS REVEALED 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 H7493894020220 0014107154

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR