BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1220463 · Received November 4, 2008

    Report

    Report Number
    2134265-2008-04185
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 5, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE MOST PROBABLE ROOT CAUSE IS DETERMINED TO BE 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, A THROMBOSIS OCCURRED. THE PHYSICIAN DIRECT STENTED A TAXUS EXPRESS2 3.5X20MM DRUG ELUTING STENT TO THE 80% STENOSED LESION LOCATED IN THE NONTORTUOUS AND NONCALICIFED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. UPON COMPLETION OF THE PROCEDURE, THE PATIENT EXPERIENCED SEVERE CHEST PAIN AND THE IMPLANTED STENT WAS FOUND TO BE FULL OF THROMBUS. ALL ATTEMPTS TO DISSOLVE THE THROMBUS BY INJECTING RELATED ANTIPLATELET MEDICATION, SUCH AS HEPARIN, WERE NOT SUCCESSFUL. THE PATIENT WAS SENT FOR EMERGENT CORONARY ARTERY BYPASS GRAFTING (CABG) SURGERY. ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 3.5X20MM 11820978

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention