BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS (R) LIBERTÉ (R)

    MDR report key: 2192010 · Received August 4, 2011

    Report

    Report Number
    2134265-2011-03105
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE SDS WAS RECEIVED WITHOUT THE MANIFOLD AND THE STENT. CONFIRMATION WAS RECEIVED FROM THE FACILITY THAT THE STENT DISLODGED OUTSIDE THE PATIENT AND WAS DISPOSED. THERE WAS A BREAK IN THE HYPOTUBE AND THE OVERALL LENGTH OF THE RECEIVED PORTION OF THE SDS WAS 124 CM. THERE IS DRIED BLOOD AND CONTRAST PRESENT. THE FRACTURE FACES WERE OVAL SHAPED, AS IF KINKED PRIOR TO SEPARATION, AND THE MATERIAL WAS JAGGED AND STRETCHED, WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). THE BALLOON WAS TIGHTLY FOLDED. THERE WERE STENT STRUT IMPRESSIONS ON THE SURFACE OF THE BALLOON, CENTERED BETWEEN THE MARKERBANDS. THE STRUT IMPRESSIONS ON THE BALLOON CONFIRMED THAT THE STENT WAS APPROPRIATELY POSITIONED AND SECURED TO THE SDS DURING MANUFACTURING. THE MID-SHAFT WAS STRETCHED 3.7 CM IN LENGTH STARTING AT THE HYPO-TUBE BOND . THE TIP WAS BUNCHED AND SLIGHTLY STRETCHED. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT MOVED ON THE BALLOON. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS LEFT CIRCUMFLEX (LCX). A 12X2.75MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT CROSS THE LESION. AN ANCHOR BALLOON TECHNIQUE WAS USED TO ADVANCE BUT SDS BUT IT STILL DID NOT CROSS. UPON REMOVAL IT WAS NOTED THAT THE CATHETER SHAFT WAS KINKED AND THE STENT HAD MOVED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT MOVED ON THE BALLOON. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS LEFT CIRCUMFLEX (LCX). A 12X2.75MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT CROSS THE LESION. AN ANCHOR BALLOON TECHNIQUE WAS USED TO ADVANCE BUT SDS BUT IT STILL DID NOT CROSS. UPON REMOVAL IT WAS NOTED THAT THE CATHETER SHAFT WAS KINKED AND THE STENT HAD MOVED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (R) LIBERTÉ (R) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893612270 13692239

    Patients

    Seq Age Sex Outcome Treatment
    1 8FR 25CM GUIDING INTRODUCER| FIELDER FC GUIDE WIRE| 8FR MACH1 AL1.0 GUIDE CATHETER