BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1953870 · Received January 10, 2011

    Report

    Report Number
    2134265-2010-05717
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 11, 2005
    Report Date
    December 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2010-05715 AND 2134265-2010-05716. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE STENT THROMBOSIS OCCURRED. THREE TAXUS EXPRESS2 STENTS, SIZES 2.75X28MM, 2.72X28MM AND 2.50X24MM, WERE IMPLANTED IN THE RIGHT CORONARY ARTERY (RCA). SIX MONTHS LATER THE STENTS THROMBOSED AND THE PATIENT UNDERWENT OPEN HEART SURGERY. FOUR AND HALF YEARS LATER AN ADDITIONAL TAXUS STENT WAS IMPLANTED IN THE LEFT MAIN ARTERY (LM). IT WAS NOTED THAT THE LM HAD NOT BEEN BYPASSED BEFORE. THE PATIENT'S CURRENT CONDITION IS OKAY. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493896824250

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 2.50X24MM TAXUS EXPRESS2 STENT| 2.75X28MM TAXUS EXPRESS2 STENT