BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1003538 · Received February 26, 2008

    Report

    Report Number
    2134265-2008-00557
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    January 26, 2008
    Report Date
    January 31, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS. 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MFR #2134265-2008-00558. IT WAS REPORTED BY THE PATIENT THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, AN ALLERGIC REACTION OCCURRED. THE PHYSICIAN IMPLANTED A 3.00X28MM TAXUS EXPRESS2 DRUG ELUTING STENT AND A 3.50X24MM TAXUS EXPRESS2 DRUG ELUTING STENT IN UNSPECIFIED LOCATIONS. TEN DAYS LATER, THE PATIENT WOKE UP ITCHING, AND SHE NOW HAS SEVERE ITCHING AND HIVES INCLUDING WHELPS ON HER SCALP. SHE SAW A DERMATOLOGIST AT NYU WHO STARTED PREDNISONE AND TOPICAL MEDICATION. THE HEALTH CARE PROVIDER HAS DISCONTINUED CRESTOR AND METOTROPOLOL. SHE ALSO DESCRIBED AREAS ON HER BODY AS "BLEEDOUTS." IT WAS FURTHER REPORTED BY THE PATIENT THAT HER SYMPTOMS ARE BEGINNING TO CLEAR. FURTHER INFORMATION 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 3.50X24MM 9801889

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other