BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS? LIBERTÉ?

    MDR report key: 3910418 · Received July 2, 2014

    Report

    Report Number
    2134265-2014-03814
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    April 28, 2014
    Report Date
    June 10, 2014
    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 EVALUATED BY MFR: THE DEVICE WAS RETURNED AND VISUAL EXAMINATION OF THE BUMPER TIP FOUND NO DAMAGE OR ISSUES WITH ITS PROFILE. THE BALLOON CONES PROFILES WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL EXAMINATION OF THE STENT FOUND NO ISSUES WITH ITS PROFILE. A VISUAL AND TACTILE EXAMINATION OF THE MIDSHAFT SECTION FOUND NO ISSUES WITH ITS PROFILE. A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE KINKING ON THE HYPOTUBE SHAFT AND THE SHAFT ITSELF WAS BROKEN IN THE REGION OF THE SEVERE KINKING. THE HYPOTUBE BROKE 795MM DISTAL FROM STRAIN RELIEF. THE HYPOTUBE MAY HAVE BROKE DUE TO THE APPLICATION OF EXCESSIVE FORCE WHICH MAY HAVE INITIALLY KINKED THE DEVICE AND THEN RESULTED IN THE HYPOTUBE BREAKING. 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 UPON THE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT THE STENT COULD NOT CROSS THE LESION. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH A VESSEL LENGTH OF 20 MM AND DIAMETER OF 3.0 MM. PRE-DILATION WAS PERFORMED WITH THE BALLOON. THE DOCTOR ATTEMPTED TO USE A TAXUS LIBERTÉ 20 X 3.00MM DRUG ELUTING STENT DELIVERY SYSTEM TO TREAT THE LESION, BUT THE STENT COULD NOT CROSS THE LESION. THE DOCTOR COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION IS STABLE. HOWEVER, RETURNED PRODUCT ANALYSIS REVEALED THE HYPOTUBE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387891 TAXUS? LIBERTÉ? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894020300 15803105

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR