BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1070476 · Received July 7, 2008

    Report

    Report Number
    2134265-2008-01894
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING A DETAILED DEVICE ANALYSIS, IT WAS NOTED THAT THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT. INITIAL VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED PROXIMAL STENT DAMAGE. SOME OF THE STRUTS WERE SEVERELY MISALIGNED. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE DEVICE MEETING SOME FORM OF RESTRICTION ON THE WITHDRAWAL OF THE DEVICE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. 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 ANY POSITIVE PRESSURE. A 0.015 ICH PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. A LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE TAXUS EXPRESS2 DIRECTIONS FOR USE (DFU). HOWEVER, THE LESION WAS MODERATELY TORTUOUS, CALCIFIED AND HAD 75% STENOSIS PRESENT. THESE COULD BE POTENTIAL CONTRIBUTING FACTORS TO THE COMPLAINT INCIDENT. ALL UNITS SHIPPED FOR THE BATCH CONFORMED TO THE PREVENTIVE MEASURES / CURRENT CONTROLS AS PER PRODUCT SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS EVENT IS OPERATIONAL CONTEXT AS THE COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS DESIGN AND MANUFACTURING SPECIFICATIONS, BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE PERFORMANCE WAS LIMITED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE, THE STENT WAS DAMAGED. THE LESION WAS 75% STENOSED, CALCIFIED, MODERATELY TORTUOUS, PROXIMAL TO DISTAL CX (CIRCUMFLEX). A 2.75X32MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS ADVANCED TO THE LESION FOLLOWING PRE-DILATION USING AN UNKNOWN BALLOON CATHETER. THE STENT DELIVERY SYSTEM WAS NOT ABLE TO CROSS THE LESION. THE PHYSICIAN ADVANCED THE DELIVERY SYSTEM SEVERAL TIMES, BUT WAS UNABLE TO CROSS. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN NOTED THAT THE PROXIMAL END OF THE STENT WAS FLARED. THE PROCEDURE WAS COMPLETED WITH IMPLANT OF A TAXUS EXPRESS2 2.75X16MM STENT. THE PATIENT DID NOT HAVE ANY INJURIES OR COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ - STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 2.75X32MM 11454446

    Patients

    Seq Age Sex Outcome Treatment
    1