BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2143209 · Received June 28, 2011

    Report

    Report Number
    2134265-2011-02502
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    March 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    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 MANUFACTURER - A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED PROXIMAL STENT DAMAGE. A NUMBER OF STRUT ROWS WERE RAISED AND MISALIGNED. THE OUTER DIAMETER OF THE STENT AREA WHERE NO DAMAGE WAS PRESENT MEASURED WITH SPECIFICATION. THE HYPOTUBE WAS BROKEN 220MM DISTAL TO THE CATHETER STRAIN RELIEF. THE HYPOTUBE WAS KINKED ALONG ITS ENTIRE LENGTH. THE BALLOON AND STENT SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. MANDREL RESISTANCE WAS ENCOUNTERED DUE TO THE PRESENCE OF SOLIDIFIED BLOOD WITHIN THE GUIDEWIRE LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. 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 (B)(6) 2011. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, DIFFICULTY CROSSING THE LESION OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. DURING THE PROCEDURE, THE PHYSICIAN COULD NOT CROSS THE LESION WITH A 2.50X32MM TAXUS LIBERTE STENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE. HOWEVER, ANALYSIS OF THE RETURNED DEVICE REVEALED STENT DAMAGE AND HYPOTUBE BREAK.

    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 - GALWAY H7493894032250 13700546

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR