BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1850309 · Received October 1, 2010

    Report

    Report Number
    2134265-2010-04290
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 10, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - THE STENT DELIVERY SYSTEM DEVICE WITH THE STENT WAS VISUALLY, TACTILELY AND MICROSCOPICALLY EXAMINED ALONG THE ENTIRE LENGTH. THERE WAS BLOOD VISIBLE IN THE DISTAL SHAFT. MICROSCOPIC EXAMINATION OF THE STENT IMPLANT IDENTIFIED DAMAGE ON THE PROXIMAL END OF THE STENT; TWO STRUTS IN THE FIRST PROXIMAL ROW WERE FLARED/BENT BACK DISTALLY. MICROSCOPIC INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/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 LESION WAS LOCATED IN AN UNSPECIFIED CORONARY ARTERY. A 3.5X12MM TAXUS LIBERTE' STENT WAS ADVANCED TO THE LESION BUT COULD NOT CROSS. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, A BENT STENT STRUT WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER TAXUS LIBERTE' STENT. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS FINE. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE LESION WAS LOCATED IN AN UNSPECIFIED CORONARY ARTERY. A 3.5X12MM TAXUS LIBERTE' STENT WAS ADVANCED TO THE LESION BUT COULD NOT CROSS. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, A BENT STENT STRUT WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER TAXUS LIBERTE' STENT. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS FINE. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    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 H7493893612350 12928212

    Patients

    Seq Age Sex Outcome Treatment
    1