BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1172505 · Received September 19, 2008

    Report

    Report Number
    2134265-2008-02745
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 8, 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

    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 CALCIFIED AND MODERATELY TORTOUS MID LEFT ANTERIOR DESCENDING ARTERY. FIRST THE PHYSICIAN DEPLOYED A 2.75X20MM TAXUS EXPRESS2 DRUG ELUTING STENT. THEN THE PHYSICIAN ADVANCED THE 2.5X12MM TAXUS EXPRESS2 DRUG ELUTING STENT TO THE DISTAL SIDE OF THE DEPLOYED STENT AND ADVANCED IT TO THE LESION, BUT WAS UNABLE TO CROSS. DURING THE ATTEMPT, THE "PHYSICIAN NOTICED THE PROXIMAL SHAFT OF THE DEVICE GOT FRACTURED OUTSIDE THE BODY". THERE WERE NO PATIENT COMPLICATIONS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. PATIENT 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 2.50X12MM 11118903

    Patients

    Seq Age Sex Outcome Treatment
    1 TERUMO 6F INTRODUCER SHEATH| LAUNCHER EBU 3.5 GUIDE CATHETER| 2.5X15MM HIRYU BALLOON CATHETER| ENCORE INFLATION DEVICE| RUNTHROUGH HC GUIDEWIRE