BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1863562 · Received October 11, 2010

    Report

    Report Number
    2134265-2010-04665
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 30, 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. THE STRUTS ON ROWS 1 & 2 WERE KINKED. 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 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 CLASSIFICATION 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 ON ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT WAS UNABLE TO CROSS THE LESION. THE 94% STENOSED LESION WAS LOCATED IN A SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY. THE LESION WAS PREDILATED WITH A 2.0X15MM MAVERICK BALLOON. A 3.0X38MM TAXUS LIBERTE' STENT WAS ADVANCED TO THE LESION, BUT COULD NOT CROSS. THE PROCEDURE WAS COMPLETED WITH ANOTHER TAXUS LIBERTE' STENT. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS STABLE. PRODUCT ANALYSIS 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 H7493894038300 12700938

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR 2.0X15MM MAVERICK BALLOON