BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1040491 · Received May 9, 2008

    Report

    Report Number
    2134265-2008-01349
    Event Type
    Injury
    Date Received
    May 9, 2008
    Report Date
    May 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    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 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

    SAME CASE AS: 2134265-2008-01348. IT WAS REPORTED, BY THE PT'S DAUGHTER, THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, LOW HEMOGLOBIN LEVELS, TRANSFUSIONS, AND IRON THERAPY HAVE OCCURRED. SINCE THE PLACEMENT OF A 2.75X24MM AND A 2.75 X 16MM TAXUS EXPRESS 2 DRUG ELUTING STENT AND STARTING ON PLAVIX, THE PT HAS HAD A LOW HEMOGLOBIN LEVELS. THE PT HAS HAD TO GO TO THE HOSPITAL EVERY MONTH FOR TRANSFUSIONS. ON THE DAY OF THIS REPORT THE PT RECEIVED 3 UNITS OF BLOOD, AS WELL AS IRON THERAPY. THE PT HAS A HISTORY OF GASTROINTESTINAL BLEEDS PRIOR TO STARTING ON PLAVIX.

    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 2.75X 24MM 9259396

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention