BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1872644 · Received October 18, 2010

    Report

    Report Number
    2134265-2010-04666
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 29, 2010
    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). A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED DISTAL STENT DAMAGE. ONE STRUT WAS RAISED ON ROW 1. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON ADVANCEMENT AND/OR WITHDRAWAL. THE BALLOON AND TIP 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. A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED KINKS ALONG THE ENTIRE LENGTH OF THE HYPOTUBE SHAFT. A 0.015 INCH PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. 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) 2010. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, THE STENT WOULD NOT CROSS THE LESION. THE 90% STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED AND TORTUOUS RIGHT CORONARY ARTERY (RCA). INTRAVASCULAR ULTRASOUND (IVUS) WAS USED. THE LESION WAS PREDILATED WITH AN UNKNOWN SIZE BALLOON. DURING THE PROCEDURE, THE PHYSICIAN COULD NOT CROSS THE LESION WITH A 2.5X28MM TAXUS LIBERTE STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE. HOWEVER, ANALYSIS OF THE RETURNED DEVICE REVEALED 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 H7493894028500 12445621

    Patients

    Seq Age Sex Outcome Treatment
    1