BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1959910 · Received January 13, 2011

    Report

    Report Number
    2134265-2010-05843
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT DEVICE EVALUATED BY MANUFACTURER - IT IS 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. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR# 213465-2010-05840. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, HYPERSENSITIVITY OCCURRED. IN (B)(6) 2010, THE LESION BEING TREATED WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). TWO 4.00X38MM TAXUS LIBERTE LONG STENTS WERE IMPLANTED. IN (B)(6) 2010, THE PATIENT WAS REFERRED TO A NEUROLOGIST BY HIS CURRENT CARDIOLOGIST. THE CARDIOLOGIST BELIEVES THE PATIENT IS HAVING A "TOXIC REACTION" TO THE 2 PREVIOUSLY IMPLANTED TAXUS LIBERTE STENTS. THE PATIENT HAS EXPERIENCED BACK AND ARM PAIN WHICH WORSENS DEPENDING ON THE WEATHER. THE PATIENT STARTED FEELING THIS WAY ABOUT 10 OR 11 WEEKS AFTER HE STOPPED TAKING MOST OF THE PRESCRIBED MEDICATIONS. THE PATIENT IS CURRENTLY ONLY TAKING ENDURE AND ASPIRIN. THE PATIENT IS ALSO EXPERIENCING FREQUENT STOMACH CRAMPS. THE RELATIONSHIP OF THE PATIENT SYMPTOMS TO THE TAXUS LIBERTE STENTS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893638400 12751302

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other 4.00X38MM TAXUS LIBERTE LONG