BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1932059 · Received December 17, 2010

    Report

    Report Number
    2134265-2010-05616
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED TO MANUFACTURER: RETURNED PRODUCT CONSISTED OF A TAXUS LIBERTE (MR) STENT DELIVERY SYSTEM (SDS) IN TWO PIECES. BLOOD AND CONTRAST WERE VISIBLE IN THE DISTAL AND MIDSHAFT OF THE DEVICE. IT WAS DETERMINED THAT THE HYPOTUBE WAS BROKEN 92CM FROM THE STRAIN RELIEF. THE HYPOTUBE FRACTURE FACES WERE OVAL SHAPED, AS IF KINKED PRIOR TO SEPARATION. THE RETURNED CATHETER WAS VISUALLY AND TACTILELY EXAMINED ALONG THE ENTIRE LENGTH OF SHAFT AND NO OTHER DAMAGE WAS SEEN OTHER THAN THE BROKEN HYPOTUBE. THE DISTAL END OF THE SDS WAS INSPECTED UNDER MAGNIFICATION AND FOUND THE TIP DAMAGED AND NO STENT 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE LESION WAS LOCATED IN THE TORTUOUS, MINIMALLY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING ARTERY. THE 2.50X12MM TAXUS LIBERTE STENT WAS PREPPED AND BEING ADVANCED THROUGH THE CATHETER WHEN THE PROXIMAL PORTION OF THE DELIVERY CATHETER SNAPPED IN HALF. THE DEVICE WAS REMOVED. THE PHYSICIAN ATTEMPTED TO USE A NON BSC STENT BUT WAS UNABLE TO DELIVER IT TO THE LESION. THE PROCEDURE ENDED AT THIS POINT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE LESION WAS LOCATED IN THE TORTUOUS, MINIMALLY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING ARTERY. THE 2.50X12MM TAXUS LIBERTE STENT WAS PREPPED AND BEING ADVANCED THROUGH THE CATHETER WHEN THE PROXIMAL PORTION OF THE DELIVERY CATHETER SNAPPED IN HALF. THE DEVICE WAS REMOVED. THE PHYSICIAN ATTEMPTED TO USE A NON BSC STENT BUT WAS UNABLE TO DELIVER IT TO THE LESION. THE PROCEDURE ENDED AT THIS POINT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AND THE PATIENT'S STATUS IS OK.

    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 - MAPLE GROVE H7493893612250 13077534

    Patients

    Seq Age Sex Outcome Treatment
    1