BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1884118 · Received October 27, 2010

    Report

    Report Number
    2134265-2010-04877
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    September 13, 2010
    Report Date
    October 5, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS 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

    (B)(4). SAME CASE AS MFR REPORT #: 2134265-2010-04876. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A VESSEL DISSECTION OCCURRED. THE PATIENT PRESENTED WITH A CURRENT MYOCARDIAL INFARCTION AND WAS REFERRED TO CARDIAC CATHETERIZATION. THE INDEX PROCEDURE TREATED THE 80% STENOSED, 3.0X28MM TARGET LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY EXTENDING INTO THE MID LAD. TREATMENT PLACED A 3.0X32MM TAXUS LIBERTE STUDY STENT. THE STENT CAUSED A GRADE C DISTAL DISSECTION AND WAS TREATED WITH A 2.5X20MM TAXUS LIBERTE STENT. THIS STENT ALSO DISSECTED AND WAS TREATED WITH A 2.5X12MM TAXUS LIBERTE STENT WITHOUT INCIDENT. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW. THE PATIENT WAS DISCHARGED TWO DAYS LATER ON ASPIRIN AND PRASUGREL. PER THE PHYSICIAN, THE EVENT RELATION TO THE STUDY DEVICES WAS LISTED AS "HIGHLY PROBABLE".

    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 H7493893620250 12796573

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention 3X32 TAXUS LIBERTE STENT