BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2112079 · Received June 2, 2011

    Report

    Report Number
    2134265-2011-01968
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    January 20, 2011
    Report Date
    May 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. PATIENT IDENTIFIER: (B)(6). DEVICE EVALUATED BY MFR. 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). IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, VESSEL JAILING OCCURRED, AND THAT POST PROCEDURE, MYOCARDIAL INFARCTION OCCURRED. THE PATIENT PRESENTED DUE TO SILENT ISCHEMIA. CARDIAC CATHETERIZATION REVEALED A 99% STENOSED AND 12MM LONG LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) WITH A REFERENCE VESSEL DIAMETER OF 3.5MM. IT WAS TREATED WITH DIRECT STENTING WITH A 3.5X16MM TAXUS LIBERTE STENT FOLLOWED BY POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. HOWEVER, POST STENT PLACEMENT IT WAS NOTED THAT THERE WAS JAILING OF THE FIRST DIAGONAL BRANCH WITH TIMI-2 FLOW AND 70% STENOSIS. THIS WAS TREATED WITH ANGIOPLASTY USING A 3.0X9MM MAVERICK BALLOON RESULTING IN 0% RESIDUAL STENOSIS. 1 DAY LATER, CARDIAC ENZYMES WERE FOUND TO BE ELEVATED CONSISTENT WITH A MYOCARDIAL INFARCTION. THE EVENT IS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED 1 DAY POST PROCEDURE. IT IS THE OPINION OF THE PHYSICIAN THAT THIS EVENT IS UNRELATED TO THE TAXUS LIBERTE 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 H7493893616350 13441509

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention