BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1111755 · Received August 12, 2008

    Report

    Report Number
    2134265-2008-02268
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS. THE STENT REMAINS IMPLANTED AND THE COMPLAINANT INDICATED THAT THE DELIVERY DEVICE WILL NOT BE RETUNED FOR EVAL; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE HISTORICAL TRENDING AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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 POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A STENT FRACTURE OCCURRED. THE PHYSICIAN IMPLANTED A 3.00X28MM TAXUS EXPRESS2 DRUG ELUTING STENT IN THE OSTIAL RIGHT CORONARY ARTERY (RCA), AND THEN PLACED A 2.75X24MM TAXUS STENT IN THE RCA. AN UNSPECIFIED AMOUNT OF TIME LATER, THE PHYSICIAN ATTEMPTED TO PERFORM INTRAVASCULAR ULTRASOUND (IVUS) IN THE RCA, BUT HAD DIFFICULTY BECAUSE THE 3.00X28MM STENT HAD FRACTURED AND A SMALL PORTION OF THE STENT WAS ''HANGING OUT INTO THE AORTA." THE PHYSICIAN GAVE UP TRYING TO IVUS THE RCA, AND PERFORMED IVUS IN THE RIGHT ANTERIOR DESCENDING AND FOUND THAT IT WAS 75% STENOSED. THE PHYSICIAN ENDED THE CASE AND DECIDED TO SENT THE PT TO SURGERY. 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 3.00X28MM

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention