BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2231678 · Received September 1, 2011

    Report

    Report Number
    2134265-2011-03674
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    June 20, 2011
    Report Date
    August 10, 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 A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND THE DEVICE WAS RETURNED TO THE COMPLAINT INVESTIGATION SITE WITH DISTAL STENT DAMAGE. STENT STRUTS FROM THE MOST DISTAL ROW WERE RAISED FROM THE BALLOON AND MISALIGNED. 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. THERE WERE KINKS IDENTIFIED ALONG THE ENTIRE LENGTH OF THE HYPOTUBE SHAFT. A 0.015 INCH PRODUCT MANDREL WAS INSERTED THROUGH THE GUIDEWIRE 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 IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS REPORTABLE BASED ON THE ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING AN STENTING TREATMENT PROCEDURE THE DEVICE WOULD NOT CROSS THE LESION. ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. THE 80% STENOSED, 10MM IN LENGTH, 3MM IN DIAMETER, ECCENTRIC AND DE NOVO TARGET LESION BEING TREATED WAS LOCATED IN THE MILDLY CALCIFIED AND MODERATELY TORTUOUS LEFT CIRCUMFLEX (LCX) ARTERY. THERE WAS A SIGNIFICANT BEND OF LESS THAN OR EQUAL TO 45 DEGREES. THE LESION WAS PRE-DILATED WITH A 2.00X15MM NON-BSC BALLOON LEAVING 50% RESIDUAL STENOSIS. A 3.00X12MM TAXUS LIBERTE STENT DELIVERY SYSTEM WAS THEN ADVANCED, HOWEVER IT WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.00X12MM TAXUS STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE. HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED 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 H7493894012300 13485129

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR 2.00X15MM SPRINTER BALLOON CATHETER| 190CM BMW GUIDE WIRE| EBU3.5 6F LAUNCHER GUIDE CATHETER