BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2021479 · Received March 17, 2011

    Report

    Report Number
    2134265-2011-00806
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    December 29, 2010
    Report Date
    February 18, 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 EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED THAT THE STENT WAS RELEASED AND DAMAGED, RESTING ON THE DEFLATED BALLOON. THE STENT WAS STRETCHED ALONG IT'S ENTIRE LENGTH OVER THE BALLOON. THE DISTAL EDGE OF THE STENT WAS POSITIONED 8MM DISTAL TO THE DISTAL EDGE OF THE DISTAL MARKERBAND. THE PROXIMAL EDGE OF THE STENT WAS POSITIONED 7MM PROXIMAL TO THE PROXIMAL EDGE OF THE PROXIMAL MARKERBAND. AN EXAMINATION OF THE BALLOON THROUGH THE STENT FOUND THAT THE BALLOON HAD BEEN INFLATED AND DEFLATED DURING THE PROCEDURE. THE STENT WAS THEN REMOVED IN ORDER TO INSPECT THE BALLOON. THE BALLOON WAS INFLATED AND DEFLATED NORMALLY. THE TIP 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. 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 ON (B)(6) 2011. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THERE WAS DIFFICULTY CROSSING THE LESION. THE LESION BEING TREATED WAS LOCATED IN THE VERY TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. PRE-DILATATION WAS PERFORMED WITH MAVERICK 1.5X15 MM BALLOON CATHETER. THE 2.50X32MM TAXUS LIBERTE STENT WAS ADVANCED AND FAILED TO CROSS THE LESION. AFTER RE-BALLOONING, THE PROCEDURE WAS COMPLETED WITH A NON BSC 33MM STENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT CONDITION IS STATED AS STABLE. RETURNED 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 H7493894032250 12841567

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR