BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1509860 · Received September 28, 2009

    Report

    Report Number
    2134265-2009-05264
    Event Type
    Malfunction
    Date Received
    September 28, 2009
    Date of Event
    July 26, 2009
    Report Date
    August 31, 2009
    Manufacturer
    BOSTON SCIENTIFIC
    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 VISUAL MICROSCOPIC EXAMINATION FOUND THAT THE DISTAL EDGE OF THE STENT WAS DAMAGED. STRUTS ON STENT ROWS 1 TO 2 FROM THE DISTAL EDGE WERE SLIGHTLY RAISED. NO 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 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. THE MFG RECORDS WERE REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND AND MET ALL SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. BSC ID: A00175275, TW: 1251852.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON ANALYSIS COMPLETED ON 08/31/2009. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, CROSSING DIFFICULTY OCCURRED. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE SEVERELY TORTUOUS, SEVERELY CALCIFIED PROXIMAL-TO-MID CIRCUMFLEX ARTERY. ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. THE PHYSICIAN ATTEMPTED TO PLACE THE 2.75X28MM TAXUS LIBERTE STENT, BUT COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A 2.75X28MM PROMUS DRUG ELUTING STENT. NO PT COMPLICATIONS WERE REPORTED. PT CONDITION IS REPORTED AS "GOOD". HOWEVER, THE RETURNED PRODUCT ANALYSIS OF THE 2.75X28MM TAXUS LIBERTE STENT REVEALED 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 2.75X28MM 11484474

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR