BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS¿ LIBERTÉ¿ LONG

    MDR report key: 2961948 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00598
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 18, 2013
    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

    (B)(4). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WITH THE DISTAL PORTION OF THE DEVICE MISSING INCLUDING THE STENTED BALLOON. THERE WAS CONTRAST IN THE INFLATION LUMEN. THE HYPOTUBE WAS DETACHED/SEPARATED 43.5 CM FROM THE STRAIN RELIEF. 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 SHAFT WAS DETACHED/SEPARATED 136 CM FROM THE STRAIN RELIEF WITH 3 CM OF THE INNER SHAFT STRETCHED AND ELONGATED, WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). MAGNIFIED INSPECTION PRESENTED NO DAMAGE OR IRREGULARITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CROSSING DIFFICULTY OR THE CONFIRMED HYPOTUBE AND SHAFT DETACHMENT AND SHAFT 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

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) THE DEVICE WAS UNABLE TO CROSS THE LESION. THE 95% STENOSED DE NOVO TARGET LESION WAS LOCATED IN THE MILD TORTUOUS AND MILD CALCIFIED RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED AND THEN A 38 X 3.00 MM TAXUS LIBERTÉ STENT DELIVERY SYSTEM WAS ADVANCED TO THE RCA; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS STABLE. HOWEVER, RETURNED PRODUCT ANALYSIS REVEALED SHAFT BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65077 TAXUS¿ LIBERTÉ¿ LONG CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493894038300 15228248

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR