BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1812315 · Received August 24, 2010

    Report

    Report Number
    2134265-2010-03582
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT.(B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL ANALYSIS FOUND THAT THE STENT WAS MOVED DISTALLY ON THE BALLOON SO THE PROXIMAL EDGE OF THE STENT WAS 13MM DISTAL TO THE PROXIMAL MARKERBAND AND DISTAL EDGE OF THE STENT WAS 45MM DISTAL TO THE DISTAL MARKERBAND. THE STENT WAS STRETCHED ALONG ITS ENTIRE LENGTH. THE SHAFT, 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 ANY POSITIVE PRESSURE. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS BATCH FOUND THAT THE DEVICES MET THEIR MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. 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

    IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE STENT MOVED ON THE BALLOON. THE LESION BEING TREATED WAS LOCATED IN THE PROXIMAL TO DISTAL LEFT CIRCUMFLEX (LCX). THE PHYSICIAN PRE-DILATED THE LESION USING A QUANTUM MAVERICK AT 14ATMS, SEVERAL TIMES. THEN THEY ATTEMPTED TO IMPLANT A NON BSC STENT, HOWEVER WERE UNABLE TO ADVANCE THE STENT PAST THE LCX. AN ADDITIONAL BALLOON AND GUIDEWIRE WERE USED FOR SUPPORT BUT WERE STILL UNABLE TO CROSS THE LESION. THE PHYSICIAN THEN ATTEMPTED TO IMPLANT A 2.50X28MM TAXUS LIBERTE STENT. WHEN THE DEVICE WAS INTRODUCED, IT BECAME CAUGHT AT THE PROXIMAL LCX AS WELL EVEN WITH SEVERAL ATTEMPTS. AFTER WITHDRAWAL, IT WAS NOTED THAT THE STENT WAS STRETCHED ON THE BALLOON. THE PROCEDURE WAS COMPLETED ONLY WITH BALLOON ANGIOPLASTY. THE PHYSICIAN STATED THE STENT HAD MOVED ON THE BALLOON ALTHOUGH THE STENT WAS STILL MOUNTED ON THE BALLOON AND NOT DISLODGED FROM THE BALLOON. THE PATIENT CONDITION WAS LISTED AS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE STENT MOVED ON THE BALLOON. THE LESION BEING TREATED WAS LOCATED IN THE PROXIMAL TO DISTAL LEFT CIRCUMFLEX (LCX). THE PHYSICIAN PRE-DILATED THE LESION USING A QUANTUM MAVERICK AT 14ATMS, SEVERAL TIMES. THEN THEY ATTEMPTED TO IMPLANT A NON BSC STENT, HOWEVER WERE UNABLE TO ADVANCE THE STENT PAST THE LCX. AN ADDITIONAL BALLOON AND GUIDEWIRE WERE USED FOR SUPPORT BUT WERE STILL UNABLE TO CROSS THE LESION. THE PHYSICIAN THEN ATTEMPTED TO IMPLANT A 2.50X28MM TAXUS LIBERTE STENT. WHEN THE DEVICE WAS INTRODUCED, IT BECAME CAUGHT AT THE PROXIMAL LCX AS WELL EVEN WITH SEVERAL ATTEMPTS. AFTER WITHDRAWAL, IT WAS NOTED THAT THE STENT WAS STRETCHED ON THE BALLOON. THE PROCEDURE WAS COMPLETED ONLY WITH BALLOON ANGIOPLASTY. THE PHYSICIAN STATED THE STENT HAD MOVED ON THE BALLOON ALTHOUGH THE STENT WAS STILL MOUNTED ON THE BALLOON AND NOT DISLODGED FROM THE BALLOON. THE PATIENT CONDITION WAS LISTED AS GOOD.

    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 H7493893628250 12791021

    Patients

    Seq Age Sex Outcome Treatment
    1