BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2151819 · Received July 6, 2011

    Report

    Report Number
    2134265-2011-02846
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    November 23, 2010
    Report Date
    June 8, 2011
    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. 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). SAME CASE AS MFR ID#: 2134265-2011-02847. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, MYOCARDIAL INFARCTION OCCURRED. THE PATIENT PRESENTED AT THE TIME OF THE INDEX PROCEDURE WITH STABLE ANGINA. CARDIAC CATHETERIZATION REVEALED 2 TARGET LESIONS. THE FIRST WAS A 17MM LONG AND 95% STENOSED LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. IT WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.5X20MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. THE SECOND WAS A 15MM LONG AND 95% STENOSED LESION LOCATED IN THE FIRST DIAGONAL CORONARY ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. IT WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.5X16MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. ONE DAY POST PROCEDURE, THE PATIENT WAS FOUND TO HAVE ELEVATED CARDIAC ENZYMES AND WAS DIAGNOSED AS HAVING A MYOCARDIAL INFARCTION. NO ACTION WAS TAKEN TO TREAT THIS EVENT. IT WAS REPORTED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED THE SAME DAY ON ASPIRIN AND PRASUGREL. IT IS THE OPINION OF THE PHYSICIAN THAT THIS EVENT IS NOT RELATED TO THE TAXUS LIBERTE STENTS.

    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 H7493893620250 13249679

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other 2.5X16MM TAXUS LIBERTE STENT