BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1230448 · Received November 7, 2008

    Report

    Report Number
    2134265-2008-04195
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    September 24, 2008
    Report Date
    October 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR BOTH THE TOP ASSEMBLY BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT TIME OF RELEASE TO DISTRIBUTION. A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE MIDDLE OF THE STENT WAS DAMAGED. THE STRUTS ON THREE ROWS WERE SLIGHTLY PUSHED TOGETHER. THIS DAMAGED SECTION WAS MEASURED 0.05MM GREATER THAN THE NORMAL STENT DIAMETER. NO KINKS OR DAMAGE WERE NOTICE ALONG THE SHAFT OF THE DEVICE. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTICED 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. A RECOMMENDED SIZED PRODUCT MANDREL (0.015 INCH) WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. SOLIDIFIED BLOOD WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. THIS INVESTIGATION WILL BE ASSIGNED THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS REPORTABLE BASED ON THE ANALYSIS COMPLETED IN 2008. IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE THE STENT COULD NOT CROSS THE LESION. THE LESION BEING TREATED WAS LOCATED IN THE MID TO PROXIMAL LEFT ANTERIOR DESCENDING (LAD). THE ANATOMY TORTUOSITY WAS SEVERE, IT WAS 90% STENOSED AND THERE WAS SIGNIFICANT RESISTANCE ENCOUNTERED DURING INSERTION. FLUSHING WAS MAINTAINED DURING PROCEDURE AND IVUS WAS NOT USED. THE PHYSICIAN ATTEMPTED TO PLACE A 3.0 X 38MM TAXUS LIBERTE STENT, THE STENT WOULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PT COMPLICATIONS. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. HOWEVER THE RETURNED PRODUCT CONFIRMED THAT THERE WAS STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 3.0 X 38MM 11858386

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR