BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1841662 · Received September 22, 2010

    Report

    Report Number
    2134265-2010-04148
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 1, 2010
    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 EVALUATION: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED PROXIMAL STENT DAMAGE. THE STRUTS WERE MISALIGNED PROXIMALLY. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON ADVANCEMENT AND/OR WITHDRAWAL. 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 POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED NO KINKS ALONG THE LENGTH OF THE HYPOTUBE SHAFT. A 0.015 INCH PRODUCT 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, STENT DAMAGE OCCURRED. ACCESS WAS OBTAIN VIA THE RADIAL ARTERY. A 2.25X24MM TAXUS LIBERTE STENT WAS IMPLANTED TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY. THE 3.5X30MM, ECCENTRIC, 90% STENOTIC, DE NOVO LESION WITH A <45 DEGREE BEND WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ADVANCED THE 2.75X32MM TAXUS LIBERTE STENT TO THE LESION, BUT WAS UNABLE TO CROSS. WHEN THE DELIVERY SYSTEM WAS REMOVED, IT WAS OBSERVED THAT THE STENT STRUTS WERE RAISED. THE PROCEDURE WAS COMPLETED WITH THE DEPLOYMENT OF A 2.75X20MM AND 2.75X16MM TAXUS LIBERTE STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, STENT DAMAGE OCCURRED. ACCESS WAS OBTAIN VIA THE RADIAL ARTERY. A 2.25X24MM TAXUS LIBERTE STENT WAS IMPLANTED TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY. THE 3.5X30MM, ECCENTRIC, 90% STENOTIC, DE NOVO LESION WITH A <45 DEGREE BEND WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ADVANCED THE 2.75X32MM TAXUS LIBERTE STENT TO THE LESION, BUT WAS UNABLE TO CROSS. WHEN THE DELIVERY SYSTEM WAS REMOVED, IT WAS OBSERVED THAT THE STENT STRUTS WERE RAISED. THE PROCEDURE WAS COMPLETED WITH THE DEPLOYMENT OF A 2.75X20MM AND 2.75X16MM TAXUS LIBERTE STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    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 H7493894032270 12863574

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR BMW 0.0014 GUIDE WIRE| EBU3.5 LAUNCHER 6F GUIDE CATHETER