BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1221230 · Received November 5, 2008

    Report

    Report Number
    2134265-2008-04222
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 IS DETERMINED TO BE ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A DISSECTION OCCURRED. THE LESION WAS PRE-DILATED WITH A 3.0X15MM NON BSC BALLOON. THE PHYSICIAN THEN ATTEMPTED TO IMPLANT A TAXUS EXPRESS2 2.75X20MM DRUG ELUTING STENT TO THE 90% STENOSED LESION LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS LEFT MAIN TRUNK (LMT) AND PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY, BUT WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN THEN ATTEMPTED TWO WIRES TECHNIQUE AND TRIED TO ADVANCE THE STENT DELIVERY SYSTEM (SDS), BUT WAS UNABLE TO CROSS THE LESION. AT THIS TIME ANGIOGRAPHY CONFIRMED A DISSECTION AT THE LAD. PER THE PHYSICIAN, THE DISSECTION RELATED TO THE CALCIFIED LESION AND WAS NOT RELATED TO THE TAXUS EXPRESS2 DEVICE. THE PHYSICIAN ATTEMPTED TO PLACE A 2.25X15MM NON BSC STENT TO THE DISSECTED AREA. IT WAS IMPLANTED SUCCESSFULLY, BUT STRONG RESISTANCE WAS FELT WHILE ADVANCING. THE STENT WAS POST DILATED WITH THE 3.0X15MM NON BSC BALLOON. A 3.5X13MM NON BSC STENT WAS THEN IMPLANTED IN THE LMT. POST IVUS WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. NO ADDITIONAL PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. PATIENT STATUS POST PROCEDURE IS NOTED AS GOOD.

    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 2.75X20M 11099822

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PT2 GUIDEWIRE| RUNTHROUGH GUIDEWIRE| MINI VISION STENT| BALANCE GUIDEWIRE| CYPHER STENT| HIRYU BALLOON| LAUNCHER GUIDE CATHETER| STAR GUIDEWIRE