BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL ELUTING STENT

    MDR report key: 690200 · Received March 16, 2006

    Report

    Report Number
    6000089-2006-00409
    Event Type
    Malfunction
    Date Received
    March 16, 2006
    Date of Event
    February 23, 2006
    Report Date
    February 23, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, DAMAGE TO THE TAXUS EXPRESS2 2.75 X 24MM STENT OCCURRED. AS THE PHYSICIAN WAS ADVANCING THE TAXUS STENT LESION, RESISTANCE WAS FELT IN THE GUIDE WIRE CATHETER. THE UNDEPLOYED STENT WAS REMOVED FROM THE PT'S BODY WHEN IT WAS DISCOVERED THAT THE STENT STRUTS WERE STICKING UP AWAY FROM THE STENT DELIVERY SYSTEM. THE LESION BEING TREATED WAS AN 80% STENOTIC VEING GRAFTY OF THE OBTUSE MARGINAL. IT IS UNK HOE THE PROCEDURE WAS COMPLETED. THERE WERE NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL ELUTING STENT DRUG ELUTING STENT NIQ BOSTON SCIENTIFIC CORP. 2.74 X 24MM 7487493

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN