BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1063637 · Received June 19, 2008

    Report

    Report Number
    2134265-2008-01731
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 30, 2008
    Report Date
    May 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. THE 2.50X8MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) WAS ADVANCED TO THE NON TORTUOUS AND NON CALCIFIED DIAGONAL VESSEL AND THE STENT WAS DEPLOYED. WHEN THE PHYSICIAN ATTEMPTED TO WITHDRAW THE DES THE SHAFT OF THE DEVICE BROKE AT THE MONORAIL SEGMENT, THE PROXIMAL PORTION OF THE BALLOON WAS REMOVED LEAVING THE DISTAL TIP OF THE STENT DELIVERY BALLOON ON THE WIRE INSIDE OF THE PT. THE WIRE WAS THEN REMOVED FROM THE PT ALONG WITH THE DISTAL PORTION OF THE BALLOON. IT WAS NOTED THAT THE PLASTIC OF THE DEVICE LOOKED EXTRUDED. THE PROCEDURE WAS COMPLETED WITH NO PT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS LISTED AS "OKAY".

    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 11394752

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR