BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL - ELUTING CORONARY STENT SYSTEM

    MDR report key: 1162193 · Received September 16, 2008

    Report

    Report Number
    2134265-2008-02670
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 5, 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, DRUG ELUTING STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE LESION WAS LOCATED IN THE SEVERELY CALCIFIED PROXIMAL LEFT CIRCUMFLEX ARTERY. THE PHYSICIAN PREDILATED THE LESION WITH A MR2 AND QUANTUM MAVERICK BALLOON CATHETER. THEN THE PHYSICIAN ADVANCED A TAXUS EXPRESS2 DRUG ELUTING STENT TO THE LESION AND SUCCESSFULLY DEPLOYED THE STENT. THE PHYSICIAN THEN ADVANCED A 2.50X8MM TAXUS EXPRESS2 DRUG ELUTING STENT TO THE LESION AND ATTEMPTED TO DEPLOY THE STENT, BUT FAILED. THE PHYSICIAN THEN WITHDREW THE STENT FROM THE PATIENT AND NOTICED THAT THE STENT WAS FLARED. THERE WERE NO PATIENT COMPLICATIONS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 2.50X8MM TAXUS EXPRESS2 DRUG ELUTING STENT. 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. 50X8MM 11316602

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS /SJM GUIDE CATHETER