BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2070906 · Received April 27, 2011

    Report

    Report Number
    2134265-2011-01546
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    July 26, 2010
    Report Date
    March 30, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. PATIENT DENTIFER: (B)(6). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, VESSEL DISSECTION OCCURRED. THE PATIENT PRESENTED WITH STABLE ANGINA (CCS CLASS 2) AND UNDERWENT CARDIAC CATHETERIZATION WHICH REVEALED 4 TARGET LESIONS. THE FIRST LESION WAS 75% STENOSED AND 14MM LONG LOCATED IN THE FIRST RIGHT POSTERIOLATERAL CORONARY ARTERY (RPL) WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THIS WAS TREATED WITH DIRECT STENTING USING A 3.0X16MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. THE SECOND LESION WAS 95% STENOSED AND 20MM LONG LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH A REFERENCE VESSEL DIAMETER OF 3.5MM. IT WAS TREATED WITH DIRECT STENTING WITH A 3.5X24MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. THE THIRD LESION WAS 95% STENOSED AND 15MM LONG AND WAS LOCATED IN THE FIRST OBTUSE MARGINAL (OM1) WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. IT WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.75X20MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. THE FOURTH LESION WAS 95% STENOSED AND 14MM LONG LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. IT WAS TREATED WITH PREDILATION AND PLACEMENT OF A 3.0X16MM TAXUS LIBERTE STENT. A GRADE "D" DISSECTION OCCURRED POST STENT PLACEMENT. THIS WAS TREATED WITH A 3.0X12MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS AND TIMI-3 FLOW. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED 11 DAYS LATER ON ASPIRIN AND PRASUGREL.

    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 H7493893616300 12778930

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention 3.0X16MM TAXUS LIBERTE STENT| 3.5X24MM TAXUS LIBERTE STENT| 2.75X20MM TAXUS LIBERTE STENT