BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS? LIBERTÉ?

    MDR report key: 3201843 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04509
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    March 6, 2013
    Report Date
    June 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WITH STENT AND THE CARRIER TUBE (HOOP), PRODUCT MANDREL AND BALLOON PROTECTOR. THERE WAS BLOOD IN THE GUIDEWIRE LUMEN. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT SECURED ON THE BALLOON. THE PROXIMAL END OF THE STENT WAS DAMAGED WITH MULTIPLE ROWS OF STRUTS BENT, FLARED AND OVERLAPPING. THE HYPOTUBE WAS KINKED 27CM FROM THE STRAIN RELIEF. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE DAMAGE. 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

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2013.   IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY, DIFFICULTY CROSSING THE LESION OCCURRED.   VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% RESTENOSED, 20MM IN LENGTH, 2.25MM IN DIAMETER, CONCENTRIC AND DE NOVO TARGET LESION BEING TREATED WAS LOCATED IN THE NON-CALCIFIED AND MODERATELY TORTUOUS LEFT CIRCUMFLEX ARTERY WITH GREATER THAN 45 BEND . THE LESION WAS PREDILATED USING AN UNSPECIFIED BALLOON CATHETER. THE 20 X 2.25MM TAXUS LIBERTE STENT COULD NOT CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.   HOWEVER, DEVICE ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301149 TAXUS? LIBERTÉ? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493894020220 15378235

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR