BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2140458 · Received June 27, 2011

    Report

    Report Number
    2134265-2011-02632
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    April 18, 2011
    Report Date
    June 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION PRODUCT. A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE IDENTIFIED PROXIMAL STENT DAMAGE. ONE STRUT WAS RAISED AT THE PROXIMAL EDGE OF THE STENT. THE TIP WAS SLIGHTLY FLARED. THIS TYPE OF DAMAGE IS CONSISTENT WITH GUIDE WIRE MOVEMENT DURING ATTEMPTS TO CROSS THE LESION. NO ISSUES WERE NOTED WITH THE BALLOON SECTION OF THE DEVICE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. THERE WERE KINKS IDENTIFIED ALONG THE ENTIRE LENGTH OF THE HYPOTUBE. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. SOLIDIFIED BLOOD WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION 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 ON (B)(6) 2011. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE A NO CROSS OCCURRED. THE 95% STENOSED DIFFUSED, ECCENTRIC LESION BEING TREATED WAS LOCATED IN THE HEAVILY CALCIFIED AND TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS PRE-DILATED WITH AN UNSPECIFIED BALLOON. THE 3.0 X 38MM TAXUS LIBERTE MONORAIL DRUG ELUTING STENT WAS ADVANCED TO THE TARGET LESION WHEN THE DEVICE WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A 3.0 X 28MM PROMUS ELEMENT STENT OVERLAPPED BY ANOTHER 3.0 X 12MM PROMUS ELEMENT STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS STABLE. UPON ANALYSIS OF THE DEVICE IT WAS NOTED THAT WERE WAS STENT DAMAGE.

    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 H7493894038300 0013094504

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR