BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2962353 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00591
    Event Type
    Death
    Date Received
    February 14, 2013
    Date of Event
    September 18, 2012
    Report Date
    January 17, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED AT THE COMPLAINT INVESTIGATION SITE FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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) CLINICAL STUDY. SAME PATIENT AS MDR#2134265-2012-04493. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, DEATH OCCURRED. IN (B)(6) 2010, THE PATIENT PRESENTED WITH UNSTABLE ANGINA. STRESS TEST REVEALED INFERIOR ISCHEMIA AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 90% STENOSED, 12 X 3.00MM TARGET LESION WAS A DE NOVO LESION LOCATED IN THE DISTAL LEFT CIRCUMFLEX ARTERY (LCX). THE TARGET LESION WAS TREATED WITH PREDILATATION AND PLACEMENT OF 2.75 X 16 MM TAXUS LIBERTE STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. IN (B)(6) 2012, THE PATIENT WAS DIAGNOSED WITH WORSENING CORONARY ARTERY DISEASE. THREE DAYS LATER, THE PATIENT DIED OF CORONARY ARTERY DISEASE; SECONDARY CAUSES WERE CONGESTIVE HEART FAILURE, HYPERTENSION, DIABETES MELLITUS AND CHRONIC RENAL FAILURE.. AT THE TIME OF THE EVENT, THE PATIENT WAS TAKING ASPIRIN AND WAS NOT ON THE STUDY DRUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64623 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death