BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1151306 · Received September 4, 2008

    Report

    Report Number
    2134265-2008-02519
    Event Type
    Injury
    Date Received
    September 4, 2008
    Report Date
    August 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PT. BECAUSE THE BATCH NUMBER FOR THIS COMPLAINT IS UNK, THE SHOP FLOOR PAPERWORK COULD NOT BE EXAMINED. THIS INVESTIGATION WILL BE ASSIGNED THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF ANTICIPATED PROCEDURAL COMPLICATION AS THE DEVICE RELATED ROOT CAUSE DOES NOT APPLY AND THE COMPLAINT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DFU, AND/OR DEVICE LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT RESTENOSIS OCCURRED. THE PHYSICIAN IMPLANTED AN UNK SIZE TAXUS EXPRESS2 DRUG ELUTING STENT IN AN UNK LOCATION. OVER THREE YEARS LATER, THE PT PRESENTED WITH A 90% STENOSIS AND REQUIRES ANOTHER STENT FOR TREATMENT. FURTHER INFO 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