BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1723930 · Received June 15, 2010

    Report

    Report Number
    2134265-2010-02605
    Event Type
    Injury
    Date Received
    June 15, 2010
    Report Date
    May 19, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, BY THE PATIENT, THAT POST-CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THAT THEY HAVE EXPERIENCED A HEART ATTACK. THE PATIENT REPORTS HAVING AN UNSPECIFIED TAXUS LIBERTE' STENT IMPLANTED IN THEIR "LEFT ARTERY". AT SOME POINT POST-PROCEDURE THE PATIENT REPORTS "I HAVE EXTREMELY GOTTEN WORSE SINCE THE STENT WAS PLACED IN MY L ARTERY . TWO HEARTACHES VERY VERY SHORT OF BREATH UNCONTROLLABLE LEVELS OF TOXINS. AND TRIGLYCERIDE LEVELS". NO FURTHER INFORMATION IS AVAILABLE.

    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 - MAPLE GROVE UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 Other