BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2063303 · Received April 19, 2011

    Report

    Report Number
    2134265-2011-01286
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED PROXIMAL STENT DAMAGE. STENT STRUT ROWS 1 AND 2 WERE SEVERELY MISALIGNED AND RAISED DISTALLY. THE TIP AND BALLOON 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 ANY POSITIVE PRESSURE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. 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

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. ACCESS WAS GAINED VIA THE FEMORAL ARTERY. THE 30MM LONG TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. A 3.0X16MM TAXUS LIBERTE STENT DELIVERY SYSTEM WAS EXAMINED PRIOR TO USE AND NO ISSUES WERE NOTED. IT WAS ADVANCED TO THE TARGET LESION, BUT IT WAS FOUND THAT THE STENT SURFACE WAS "NOT SMOOTH" AS A STENT STRUT WAS LIFTED, SO THAT THE DEVICE COULD NOT CROSS THE LESION. ANOTHER OF THE SAME DEVICE USED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. ACCESS WAS GAINED VIA THE FEMORAL ARTERY. THE 30MM LONG TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. A 3.0X16MM TAXUS LIBERTE STENT DELIVERY SYSTEM WAS EXAMINED PRIOR TO USE AND NO ISSUES WERE NOTED. IT WAS ADVANCED TO THE TARGET LESION, BUT IT WAS FOUND THAT THE STENT SURFACE WAS "NOT SMOOTH" AS A STENT STRUT WAS LIFTED, SO THAT THE DEVICE COULD NOT CROSS THE LESION. ANOTHER OF THE SAME DEVICE USED SUCCESSFULLY. 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 H7493894016300 13349463

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR