BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1771723 · Received July 28, 2010

    Report

    Report Number
    2134265-2010-03196
    Event Type
    Malfunction
    Date Received
    July 28, 2010
    Date of Event
    June 29, 2010
    Report Date
    July 1, 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 EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED PROXIMAL STENT DAMAGE. THE STRUTS ON ROWS 1-2 FROM THE PROXIMAL EDGE ARE MISALIGNED. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON ADVANCEMENT AND/OR WITHDRAWAL. THE 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 POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED THAT THE ENTIRE LENGTH OF THE LUMEN WAS KINKED. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. A 0.015 INCH PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. SOLIDIFIED BLOOD WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. 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 STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE 100% STENOSED CHRONIC TOTAL OCCLUSION WAS LOCATED IN A MILDLY CALCIFIED AND SEVERELY TORTUOUS LEFT CIRCUMFLEX ARTERY. THE VASCULAR ACCESS SITE WAS RIGHT RADIAL. THERE WAS A FORTY FIVE DEGREE BEND IN THE LESION. THE LESION LENGTH WAS 22MM WITH A DIAMETER OF 2.25MM. THE LESION WAS DE NOVO AND THE SHAPE WAS ECCENTRIC. THE LESION WAS PREDILATED WITH A NON BSC BALLOON WHICH WAS INFLATED SIX TIMES AT TWELVE ATMOSPHERES EACH TIME FOR 9 SECONDS. THE PERCENTAGE OF STENOSIS AFTERWARDS WAS 50%. THE PHYSICIAN ATTEMPTED TO IMPLANT THE 2.25X24MM TAXUS LIBERTE STENT, HOWEVER IT WAS UNABLE TO CROSS THE LESION DUE TO THE VESSEL TORTUOUSITY. THE PHYSICIAN WITHDREW THE STENT AND FOUND THE STENT STRUTS WERE RAISED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO SYMPTOMS WERE OBSERVED. THE PATIENT STATUS IS LISTED AS STABLE.

    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 H7493894024220 12957031

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR BMW 0.0014¿¿ GUIDE WIRE| EBU3.5 LAUNCHER 6F| RYUJIN BALLOON 1.25*15MM