BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS (R) LIBERTÉ (R)

    MDR report key: 2191827 · Received August 4, 2011

    Report

    Report Number
    2134265-2011-03112
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 8, 2011
    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 EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE IDENTIFIED STENT DAMAGE. THE STENT MOVED DISTALLY ON THE BALLOON. THE DISTAL SECTION OF THE STENT WAS STRETCHED TO APPROXIMATELY 5MM FROM THE TIP AND STRUTS WERE MISALIGNED. STRUTS AT THE PROXIMAL END OF THE STENT WERE RAISED DISTALLY AND MISALIGNED. THE STENT WAS APPROX 5MM FROM THE PROXIMAL MARKERBAND. THE TIP WAS SLIGHTLY PINCHED. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE TIP BEING PUSHED UP AGAINST A RESTRICTION, DURING ATTEMPTS TO CROSS THE LESION. NO ISSUES WERE NOTED WITH THE BALLOON SECTION OF THE DEVICE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. KINKS WERE PRESENT THROUGHOUT THE ENTIRE LENGTH OF THE CATHETER. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. SOLIDIFIED BLOOD WAS PRESENT WITHIN THE TIP AND ON THE BALLOON, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. 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).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE 99% STENOSED LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS LEFT CIRCUMFLEX ARTERY (LCX). THE PHYSICIAN TRIED THE ANCHOR BALLOON TECHNIQUE. THE TAXUS LIBERTE (MR) 16 X 3.00MM STENT DELIVERY SYSTEM WAS ADVANCED AND WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT AND FOUND THE STENT STRUT LIFTED UP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE 99% STENOSED LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS LEFT CIRCUMFLEX ARTERY (LCX). THE PHYSICIAN TRIED THE ANCHOR BALLOON TECHNIQUE. THE TAXUS LIBERTE (MR) 16 X 3.00MM STENT DELIVERY SYSTEM WAS ADVANCED AND WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT AND FOUND THE STENT STRUT LIFTED UP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (R) LIBERTÉ (R) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893616300 0014150274

    Patients

    Seq Age Sex Outcome Treatment
    1