BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1842764 · Received September 23, 2010

    Report

    Report Number
    2134265-2010-04149
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 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: THE DEVICE WAS RECEIVED WITH THE PRODUCT MANDREL INSERTED AND IT COULD NOT BE REMOVED. A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED STENT DAMAGE. ONE STRUT IN THE MIDDLE OF THE STENT WAS RAISED. 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. 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 STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 4.5X15MM, 85% STENOTIC LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. THE PHYSICIAN PREDILATED THE LESION WITH A 2.5X20MM UNSPECIFIED BALLOON AND THEN ADVANCED THE 4.50X16MM 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 NOT SMOOTH. THE PROCEDURE WAS COMPLETED WITH DILATION OF THE LESION WITH A QUANTUM MAVERICK BALLOON AND THE DEPLOYMENT OF A NEW 4.50X16MM TAXUS LIBERTE STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND STATUS IS REPORTED AS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 4.5X15MM, 85% STENOTIC LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. THE PHYSICIAN PREDILATED THE LESION WITH A 2.5X20MM UNSPECIFIED BALLOON AND THEN ADVANCED THE 4.50X16MM 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 NOT SMOOTH. THE PROCEDURE WAS COMPLETED WITH DILATION OF THE LESION WITH A QUANTUM MAVERICK BALLOON AND THE DEPLOYMENT OF A NEW 4.50X16MM TAXUS LIBERTE STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND STATUS IS REPORTED AS 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 H7493894016450 0012749759

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR