BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1181128 · Received September 30, 2008

    Report

    Report Number
    2134265-2008-02840
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    March 1, 2008
    Report Date
    September 2, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, 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 BY THE PT'S WIFE, THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, POSSIBLE MILD CONGESTIVE HEART FAILURE OCCURRED. SINCE THE 2.75X12MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS PLACED, THE PT'S QUALITY OF LIFE IS NOT AS GOOD AS IT HAD BEEN PREVIOUSLY. THE PT IS "NOT REALLY HIMSELF AND HE HAS NOT FELT AS GOOD AS BEFORE STENT IMPLANTATION". APPROX TEN MONTHS POST THE STENT IMPLANT, THE PT BEGAN EXPERIENCING SHORTNESS OF BREATH AND LABORED BREATHING. FIVE DAYS LATER, A LUNG FUNCTION TEST "SEEMED TO BE" NORMAL AND A CARDIAC CATHETERIZATION REVEALED NO NEW BLOCKAGE. "THE PT IS STILL BEING EVALUATED BUT THE PHYSICIAN THINKS IT MAY BE MILD CONGESTIVE HEART FAILURE." ADDITIONAL INFO WAS REQUESTED FROM THE PHYSICIAN, BUT NOT PROVIDED.

    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 2.75X12 MM 9145718

    Patients

    Seq Age Sex Outcome Treatment
    1 Other