BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1318372 · Received February 23, 2009

    Report

    Report Number
    2134265-2008-03490
    Event Type
    Malfunction
    Date Received
    February 23, 2009
    Date of Event
    July 13, 2008
    Report Date
    September 2, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND LTD.
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED DISTAL STENT DAMAGE. SOME OF THE STENT STRUTS WERE MISALIGNED. THE OUTER DIAMETER (OD) OF THE DAMAGE FOUND ON THE STENT WAS MEASURED AT APPROXIMATELY 1.20MM. THE OD OF THE AREA WHERE THERE WAS NO DAMAGE FOUND WAS MEASURED AT APPROXIMATELY 1.08MM. THE MIDSHAFT WAS SEVERELY STRETCHED. THE DAMAGE FOUND ON THE MIDSHAFT WAS MEASURED AT APPROXIMATELY 17CM PROXIMAL TO THE PORT OF THE DEVICE. THE SHAFT POLYMER EXTRUSION WAS KINKED. THE KINKS WERE MEASURED IN LENGTH AT 3CM DISTAL TO THE PORT. VISUAL EXAMINATION OF THE TIP REVEALED TIP DAMAGE. THE TIP WAS FLARED. THE BALLOON WAS VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH ITS PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO ANY POSITIVE PRESSURE. A 0.015 INCH PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS CONSIDERED OPERATIONAL CONTEXT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE PERFORMANCE OF THE DEVICE WAS LIMITED.

    Description of Event or Problem · 1

    EVENT IS NOW REPORTABLE BASED ON ANALYSIS COMPLETED ON 09/02/2008. IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THERE WAS DIFFICULTY ADVANCING THE STENT TO THE TARGET LESION. THE LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS OSTIAL RIGHT CORONARY ARTERY. THE PHYSICIAN TRIED TO USE DUAL GUIDE WIRE TECHNOLOGY TO PERFORM THE STENTING. DURING THE PROCEDURE, THE 2.75X28MM TAXUS LIBERTE STENT SYSTEM ENTANGLED WITH ONE OF THE GUIDEWIRES AND COULD NOT BE DELIVERED TO THE TARGET LESION. THE PHYSICIAN RETRIEVED THE STENT AND USED ANOTHER PRODUCT TO CONTINUE THE PROCEDURE. THE PATIENT STATUS IS STABLE WITH NO COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC IRELAND LTD. 2.75X28MM 11512533

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR