BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1161299 · Received September 15, 2008

    Report

    Report Number
    2134265-2008-02644
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    July 3, 2008
    Report Date
    August 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS PARTICULAR BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE MOST PROBABLE ROOT CAUSE OF THIS EVENT IS ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    TAXUS EXPRESS2 JAPAN POST MARKET SURVEILLANCE STUDY. SAME CASE AS MFR REPORT #: 2134265-2008-02643. IT WAS REPORTED THAT 175 DAYS FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE THE PATIENT DEVELOPED IN-STENT RESTENOSIS. THE INDEX PROCEDURE TREATED A 70% STENOSED, 3.0X35.4MM LESION OF THE PROXIMAL LAD (LEFT ANTERIOR DESCENDING). TREATMENT CONSISTED OF PREDILATION USING A 2.5X20MM BALLOON, PLACEMENT OF TWO TAXUS EXPRESS2 DRUG ELUTING STENTS (3.0X32MM AND 3.0X8MM), POST DILATION, AND CONFIRMATION WITH IVUS (INTRAVASCULAR ULTRASOUND). THE PATIENT WAS DISCHARGED TWO DAYS POST PROCEDURE ON ASA AND PLAVIX. THE PATIENT DEVELOPED IN-STENT RESTENOSIS 175 DAYS FOLLOWING THE INDEX PROCEDURE. THE PROXIMAL LAD WAS TREATED WITH ANOTHER MANUFACTURER'S DRUG ELUTING STENT AND DISCHARGED TWO DAYS POST PROCEDURE. THE PATIENT WAS REPORTED TO BE TAKING ASA AND PLAVIX AT THE TIME OF THIS EVENT.

    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 CORPORATION 3.0X8MM 9804043

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention