BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2123930 · Received June 14, 2011

    Report

    Report Number
    2134265-2011-02201
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT A 3.00X32MM TAXUS LIBERTE STENT WAS DEPLOYED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) RATHER THAN A 3.00X24MM TAXUS LIBERTE STENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE STENT THROMBOSIS OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE 3.0X28MM PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PREDILATED THEN A 3.00X24MM TAXUS LIBERTE STENT WAS DEPLOYED IN THE LESION AT 12 ATMS FOR 30 SECONDS. IVUS WAS PERFORMED AND IT WAS NOTED THAT THE STENT WAS WELL POSITIONED AND APPOSED IN THE LESION. THE PATIENT WAS PUT ON ASPIRIN AND CLOPIDOGREL AND WAS DISCHARGED FROM THE HOSPITAL TEN DAYS LATER. NINE MONTHS LATER THE PATIENT RETURNED FOR A FOLLOW UP APPOINTMENT AND THROMBOSIS WAS CONFIRMED IN THE PREVIOUSLY DEPLOYED TAXUS LIBERTE STENT. TREATMENT WAS NOT PERFORMED ON THE THROMBOSIS AS THE PATIENT WAS ASYMPTOMATIC AND THERE WAS TIMI 3 FLOW. IT WAS NOTED THAT THE PATIENT HAD DISCONTINUED USE OF ANTIPLATELET MEDICATION AT HER OWN DISCRETION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TWO DAYS LATER.

    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 H7493893632300

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other