BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2090277 · Received May 16, 2011

    Report

    Report Number
    2134265-2011-01662
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    March 16, 2011
    Report Date
    April 20, 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

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED THAT THE DEVICE WAS RETURNED WITH A KINKED PIGTAIL MANDREL INSIDE THE LUMEN CAUSING THE TIP TO KINK. THE MANDREL WAS REMOVED WITH MODERATE FORCE AND WAS KINKED AT TWO POINTS, 18MM AND 25MM DISTAL TO THE PIGTAIL END. THE STENT WAS MISALIGNED AND SQUASHED AND STRUTS WERE RAISED FROM THE BALLOON AT POINTS ALONG IT'S LENGTH. THE TIP WAS DAMAGED. THE DISTAL EDGE OF THE TIP HAD A JAGGED EDGE. THERE WAS A KINK IN THE MID-SHAFT 10MM DISTAL TO THE PORT. THE BALLOON SECTION OF THE DEVICE WAS VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH IT'S PROFILE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEX AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON INVESTIGATION COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING A CORONARY ARTERY TREATMENT PROCEDURE THERE WAS DIFFICULTY CROSSING THE LESION. THE 81% STENOSED LESION WAS LOCATED IN A SEVERELY CALCIFIED AND SEVERELY TORTUOUS RIGHT CORONARY ARTERY. THE PHYSICIAN PRE-DILATATED THE LESION WITH A 2.5X20MM MAVERICK BALLOON AND THE 3.5X24MM TAXUS STENT WAS ADVANCED. DUE TO HEAVY CALCIFICATION AND TORTUOSITY OF THE LESION, THE STENT COULD NOT CROSS THE LESION. AFTER RE-BALLOONING THE LESION, THE PROCEDURE WAS COMPLETED WITH A 3.5X24MM PROMUS ELEMENT STENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT CONDITION IS STABLE. HOWEVER, 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 H7493894024350 0013020841

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR 2.5X20MM MAVERICK BALLOON