BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1904573 · Received November 22, 2010

    Report

    Report Number
    2134265-2010-05228
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 27, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. 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 #: 2134265-2010-05220, 2134265-2010-05227, 2134265-2010-05229. IT WAS REPORTED THAT FOLLOWING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE INDEX PROCEDURE TREATED 3 LESIONS. THE FIRST TARGET LESION WAS A 50% STENOSED, 4.5X10MM BIFURCATED TARGET LESION LOCATED IN THE LEFT MAIN CORONARY ARTERY EXTENDING INTO THE PROXIMAL LEFT CIRCUMFLEX ARTERY. TREATMENT PLACED A 3.5X20MM TAXUS LIBERTE STENT USING A DIRECT STENTING TECHNIQUE AND UTILIZED POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. THE SECOND TARGET LESION WAS A 75% STENOSED, 3.5X22MM TARGET LESION LOCATED IN THE 1ST OBTUSE MARGINAL BRANCH. TREATMENT PLACED A 3.0X28MM TAXUS LIBERTE STENT USING A DIRECT STENTING TECHNIQUE RESULTING IN 10% RESIDUAL STENOSIS. THE THIRD TARGET LESION WAS A 50% STENOSED, 3.4X52MM LONG LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) EXTENDING INTO THE MID RCA. TREATMENT PLACED TWO OVERLAPPING TAXUS LIBERTE STENTS (3.0X38MM, 3.0X20MM) USING A DIRECT STENTING TECHNIQUE RESULTING IN 0% RESIDUAL STENOSIS. ONE DAY POST THE INDEX PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN AND POSITIVE TROPONIN ELEVATION CONSISTENT WITH A MYOCARDIAL INFARCTION. THE EVENT WAS TREATED WITH SUBLINGUAL NITROGLYCERIN AND MORPHINE. THE CHEST PAIN RESOLVED AND THE PATIENT WAS DISCHARGED LATER THE SAME DAY ON ASPIRIN AND PRASUGREL. PER THE PHYSICIAN, THE EVENT WAS LISTED AS "POSSIBLY RELATED" TO THE STUDY STENT.

    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 H7493893638300 13493941

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention 3.5X20MM TAXUS LIBERTE STENT| 3.0X28MM TAXUS LIBERTE STENT| 3.0X20MM TAXUS LIBERTE STENT