BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1242909 · Received November 19, 2008

    Report

    Report Number
    2134265-2008-04383
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    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 EVALUATION: 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 RECORD FOR THIS PARTICULAR BATCH SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED DIFFICULTY IS DETERMINED TO BE OPERATIONAL CONTEXT DUE TO THE ANATOMICAL AND/OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) DRUG ELUTING STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE 90% STENOTIC LESION WAS LOCATED IN THE AVERAGE TORTUOUS AND NON CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. THE PHYSICIAN ADVANCED THE 3.5X28MM TAXUS EXPRESS2 DRUG ELUTING STENT TO THE LESION, BUT WAS UNABLE TO CROSS. THERE WERE NO PT COMPLICATIONS. WHEN THE DEVICE WAS REMOVED IT WAS OBSERVED THAT THE DISTAL EDGE OF THE STENT WAS LIFTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. PT STATUS IS REPORTED 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 3.50X28MM 11188212

    Patients

    Seq Age Sex Outcome Treatment
    1 TERUMO 7F INTRODUCER SHEATH| 3.0X15MM HIRYU BALLOON CATHETER| LAUNCHER SAL1.0 GUIDE CATHETER| RUNTHROUGH HC GUIDEWIRE| ENCORE INFLATION DEVICE