BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1963981 · Received January 19, 2011

    Report

    Report Number
    2134265-2011-00110
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    August 16, 2010
    Report Date
    January 13, 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

    DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE IS EVALUATED BY MANUFACTURER - A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED PROXIMAL STENT DAMAGE. ROWS AT THE PROXIMAL END OF THE STENT WERE MISALIGNED. THE OUTER DIAMETER OF THE STENT DAMAGE WAS MEASURED AND WAS APPROXIMATELY 1.72MM. THERE WERE ALSO KINKS IDENTIFIED ALONG THE ENTIRE LENGTH OF THE HYPOTUBE SHAFT. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. 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. SOLIDIFIED BLOOD WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. A 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 CLASSIFICATION IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE 75% STENOSED LESION WAS LOCATED IN THE OSTIUM OF A SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS PREDILATED WITH AN UNSPECIFIED DEVICE. A 2.75X38MM TAXUS LIBERTE' STENT WAS ADVANCED TO THE LESION, BUT COULD NOT CROSS. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS STABLE. PRODUCT ANALYSIS REVEALED THAT THERE WAS STENT DAMAGE.

    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 H7493894038270 0012572417

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR