BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS® LIBERTÉ® LONG

    MDR report key: 3122584 · Received May 21, 2013

    Report

    Report Number
    2134265-2013-03458
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    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: THE COMPLAINT DEVICE WAS RECEIVED FOR ANALYSIS. A VISUAL EXAMINATION OF THE RETURNED DEVICE IDENTIFIED NO KINKS ALONG THE ENTIRE LENGTH OF THE DEVICE. AN EXAMINATION OF THE CRIMPED STENT FOUND THAT THE DISTAL EDGE OF THE STENT WAS DAMAGED. THE DISTAL END OF THE STENT WAS LIFTED AND THE STENTS WERE RAISED AND MISALIGNED. THIS TYPE OF DAMAGE TO THE STENT IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DISTAL END OF THE STENT, POSSIBLY DURING THE PHYSICIAN'S FAILED ATTEMPTS TO CROSS THE LESION. 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

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS A DE NOVO LESION LOCATED IN THE CALCIFIED AND SEVERELY TORTUOUS RIGHT CORONARY ARTERY. A 38 X 3.50MM TAXUS LIBERTÉ LONG STENT WAS SELECTED TO TREAT THE TARGET LESION. AFTER PREDILATATION WITH AN UNSPECIFIED BALLOON, THIS DEVICE WAS ADVANCED TO THE LESION. HOWEVER, DESPITE SEVERAL ATTEMPTS IT FAILED TO CROSS THE LESION. IT WAS REMOVED AND THE DISTAL PART OF THE STENT STRUT WAS FOUND TO BE LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS A DE NOVO LESION LOCATED IN THE CALCIFIED AND SEVERELY TORTUOUS RIGHT CORONARY ARTERY. A 38 X 3.50MM TAXUS LIBERTÉ LONG STENT WAS SELECTED TO TREAT THE TARGET LESION. AFTER PREDILATATION WITH AN UNSPECIFIED BALLOON, THIS DEVICE WAS ADVANCED TO THE LESION. HOWEVER, DESPITE SEVERAL ATTEMPTS IT FAILED TO CROSS THE LESION. IT WAS REMOVED AND THE DISTAL PART OF THE STENT STRUT WAS FOUND TO BE LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225066 TAXUS® LIBERTÉ® LONG CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893638350 14839059

    Patients

    Seq Age Sex Outcome Treatment
    1