BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1213718 · Received October 22, 2008

    Report

    Report Number
    2134265-2008-03105
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Report Date
    September 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG DOCUMENTATION FOR THIS BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECS AT THE TIME OF RELEASE TO DISTRIBUTION. A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE PROXIMAL EDGE OF THE STENT WAS DAMAGED. STRUTS ON STENT ROWS ONE TO TWO FROM THE PROXIMAL EDGE WERE RAISED AT 90 DEGREES TO THE NORMAL POSITION OF THE STRUTS. THE HYPOTUBE HAD KINKED APPROX 31.0 CM DISTAL FROM THE CATHETER STRAIN RELIEF. NO OTHER KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. THE BALLOON AND TIP 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 MOST PROBABLE ROOT CAUSE OF THIS EVENT IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE STENT COULD NOT CROSS THE SEVERELY TORTUOUS, SEVERELY CALCIFIED, 73% STENOSED CIRCUMFLEX LESION. NO PT INJURIES OR COMPLICATIONS WERE REPORTED AND THE PT WAS REPORTED TO BE "GOOD". 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 CORPORATION 4.0X16MM 11343910

    Patients

    Seq Age Sex Outcome Treatment
    1