BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1040086 · Received May 7, 2008

    Report

    Report Number
    2134265-2008-01325
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 16, 2008
    Report Date
    April 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT EMBOLIZATION OCCURRED. THE 99% STENOSED LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED, AVERAGE TORTUOUS CIRCUMFLEX (CX) ARTERY. THE LESION WAS PREDILATED WITH A 2.5X15 MM NON-BSC BALLOON, INFLATED TO 16 ATMS FOR 30 SECONDS. WHEN THE PHYSICIAN ATTEMPTED TO PLACE THE 3.00X20 MM TAXUS EXPRESS2 DRUG ELUTING STENT, RESISTANCE WAS FELT. THE STENT HAD BEEN PARTIALLY INFLATED TO 3-6 ATMS. THE PHYSICIAN TRIED TO WITHDRAW THE STENT, BUT THE STENT DISLODGED IN THE LEFT MAIN AROUND THE TIP OF THE GUIDE CATHETER AND WAS ABLE TO BE REMOVED WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER TAXUS STENT. PT STATUS 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 3.00X20 MM 9682575

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OTTIMO BALLOON