BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1963252 · Received January 19, 2011

    Report

    Report Number
    2134265-2011-00004
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 30, 2010
    Report Date
    December 30, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED PROXIMAL STENT DAMAGE. A NUMBER OF ROWS AT THE PROXIMAL END OF THE STENT WERE MISALIGNED AND RAISED. THE DEVICE WAS RETURNED WITH A MANDREL STUCK INSIDE DUE TO THE PRESENCE OF SOLIDIFIED BLOOD WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. THE MANDREL WAS REMOVED WITH MODERATE FORCE. 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 POSITIVE PRESSURE. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 85% STENOSED LESION MEASURING 2.25MM IN DIAMETER AND 26MM IN LENGTH WAS LOCATED IN A MODERATELY CALCIFIED DISTAL LEFT CIRCUMFLEX ARTERY. THE LESION WAS PREDILATED WITH AN UNSPECIFIED BALLOON. A 2.25X28MM TAXUS LIBERTE' STENT WAS ADVANCED TO THE LESION BUT COULD NOT CROSS. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, DAMAGED STRUTS WERE NOTED. THE LESION WAS PREDILATED AGAIN AND THE PROCEDURE WAS COMPLETED WITH ANOTHER TAXUS LIBERTE' STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 85% STENOSED LESION MEASURING 2.25MM IN DIAMETER AND 26MM IN LENGTH WAS LOCATED IN A MODERATELY CALCIFIED DISTAL LEFT CIRCUMFLEX ARTERY. THE LESION WAS PREDILATED WITH AN UNSPECIFIED BALLOON. A 2.25X28MM TAXUS LIBERTE' STENT WAS ADVANCED TO THE LESION BUT COULD NOT CROSS. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, DAMAGED STRUTS WERE NOTED. THE LESION WAS PREDILATED AGAIN AND THE PROCEDURE WAS COMPLETED WITH ANOTHER TAXUS LIBERTE' STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    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 H7493894028220 13593385

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR