BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1132742 · Received August 22, 2008

    Report

    Report Number
    2134265-2008-02422
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    June 23, 2008
    Report Date
    July 30, 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

    DEVICE ANALYSIS. PRODUCT ANALYSIS FOUND THAT THE STENT HAD MOVED 3.5MM DISTALLY ON THE BALLOON AND THERE WAS PROXIMAL STENT DAMAGE. THE RETURNED CATHETER WAS VISUALLY AND TACTILETLY INSPECTED ALONG THE ENTIRE LENGTH AND THE ONLY DAMAGE FOUND WAS MOVEMENT OF THE STENT ON THE BALLOON AND PROXIMAL STENT DAMAGE. THE PROXIMAL STENT DAMAGE EXTENDED 270 DEGREES AROUND THE STENT AND AFFECTED TWO SEGMENTS. UNDER MAGNIFICATION, THE STENT IMPRESSION COULD STILL BE SEEN ON THE BALLOON INDICATING THAT THE STENT WAS ORIGINALLY CRIMPED IN THE PROPER LOCATION DURING MANUFACTURING WITH RESPECT TO THE MARKERBANDS. IT SHOULD BE NOTED WE COULD NOT CONFIRM A SHAFT KINK ON THE RETURNED UNIT. THE MANUFACTURING RECORDS FOR THIS BATCH WERE REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT WILL BE CONSIDERED OPERATIONAL CONTEXT DUE TO THE LIKELIHOOD OF ANATOMICAL AND OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE WHICH CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON 07/30/2008. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A SHAFT KINK OCCURRED. THE LESION WAS CALCIFIED AND SEVERELY TORTUOUS (LOCATION UNKNOWN). WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE 2.50X24MM TAXUS EXPRESS2 DRUG TO THE LESION, AND WHILE VIBRATING THE STENT DELIVERY SYSTEM THE PROXIMAL SHAFT KINKED. THE PROCEDURE WAS NOT COMPLETED AS THERE WAS NOT ANOTHER OF THE SAME SIZE DEVICE AVAILABLE. THE PT CONDITION IS REPORTED AS GOOD. HOWEVER, PRODUCT ANALYSIS REVEALED STENT DAMAGE AND THE STENT HAD MOVED ON THE BALLOON.

    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 2.50X24MM 11491293

    Patients

    Seq Age Sex Outcome Treatment
    1