BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2980872 · Received February 27, 2013

    Report

    Report Number
    2134265-2013-00917
    Event Type
    Death
    Date Received
    February 27, 2013
    Date of Event
    December 9, 2012
    Report Date
    January 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). THE 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

    (B)(4). IT WAS REPORTED POST A PERCUTANEOUS CORONARY INTERVENTION, THE PATIENT EXPIRED. IN (B)(6) 2011 THE PATIENT PRESENTED WITH CHEST PAIN AND HYPONATREMIA AND WAS DIAGNOSED WITH UNSTABLE ANGINA AND MYOCARDIAL INFARCTION AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 90% STENOSED AND 12 MM LONG DE-NOVO TARGET LESION WITH A PRE-EXISTING THROMBUS WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. THE TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF A 4.0 X 20 MM TAXUS LIBERTE STUDY STENT, RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN AND PRASUGREL. IN (B)(4) 2012 THE PATIENT EXPIRED DUE TO UNKNOWN CAUSE. AN AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85501 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893720400 13408989

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death