BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3812188 · Received May 15, 2014

    Report

    Report Number
    2134265-2014-02615
    Event Type
    Death
    Date Received
    May 15, 2014
    Date of Event
    December 20, 2011
    Report Date
    April 18, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS NOT 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

    SAME CASE AS MDR ID: 2134265-2014-02616. (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT PATIENT DEATH OCCURRED. IN (B)(6) 2010, THE PATIENT PRESENTED WITH DYSPNEA AND ABNORMAL RESULTS OF A STRESS TEST INDICATING POSSIBLE LATERAL WALL ISCHEMIA. THE PATIENT WAS DIAGNOSED WITH STABLE ANGINA AND SILENT ISCHEMIA. CARDIAC CATHETERIZATION WAS RECOMMENDED. THE INDEX PROCEDURE WAS PERFORMED. TARGET LESION #1 WAS A DE NOVO LESION LOCATED IN THE 1ST OBTUSE MARGINAL (OM) WITH 80% STENOSIS AND WAS 16 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 X 20 MM TAXUS LIBERTÉ STENT. FOLLOWING POST- DILATATION,RESIDUAL STENOSIS WAS 0%. TARGET LESION #2 WAS A DE NOVO LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WITH 80% STENOSIS AND WAS 26 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5MM. SUBSEQUENTLY, THE LESION WAS TREATED WITH DIRECT PLACEMENT OF USING A 3.00 X 32 MM TAXUS LIBERTÉ STENT, WITH 0% RESIDUAL STENOSIS. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2011, AT AN UNSPECIFIED TIME, THE PATIENT DIED DUE TO AN UNKNOWN CAUSE. THE STUDY DRUG WAS LAST TAKEN ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290046 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893620300 13002758

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death