BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1022599 · Received April 1, 2008

    Report

    Report Number
    2134265-2008-00921
    Event Type
    Injury
    Date Received
    April 1, 2008
    Report Date
    March 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO DEVICE WAS RECEIVED FOR ANALYSIS, IT IS NOT POSSIBLE TO PERFORM ANY INSPECTIONS ON THE DEVICE, THEREFORE, IT IS NOT POSSIBLE TO DETERMINE IF ANY ISSUES EXISTED WITH THE ACTUAL UNIT THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. BECAUSE THE BATCH NUMBER FOR THIS COMPLAINT IS UNKNOWN, THE SHOP FLOOR PAPERWORK COULD NOT BE EXAMINED. THE EXACT CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED; THEREFORE, THE MOST PROBABLE ROOT CAUSE WILL BE DOCUMENTED AS ANTICIPATED PROCEDURAL COMPLICATION DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DIRECTIONS FOR USE, AND/OR DEVICE LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT THROMBOSIS OCCURRED. THE PHYSICIAN IMPLANTED AN UNKNOWN SIZE TAXUS EXPRESS2 DRUG ELUTING STENT IN AN UNSPECIFIED LOCATION. AN UNKNOWN AMOUNT OF TIME LATER, THE PATIENT PRESENTED, AND IT WAS NOTED THAT THE STENT HAD OCCLUDED. THE PATIENT WAS NOT ON PLAVIX AT THE TIME OF THE EVENT. THE PHYSICIAN TREATED THE THROMBOSIS WITH TWO LIBERTE BARE METAL STENTS. FURTHER INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention