BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2991054 · Received March 6, 2013

    Report

    Report Number
    2134265-2013-01120
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    January 18, 2013
    Report Date
    February 5, 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

    (B)(6). DEVICE IS 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 SPECIFICATION. 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). SAME CASE AS MDR# 2134265-2013-01114, 2134265-2013-01115, 2134265-2013-01116, 2134265-2013-01117, 2134265-2013-01118 AND 2134265-2013-01121. SAME PATIENT AS MDR# 2134265-2012-00848, 34265-2012-00850, 2134265-2012-01912, AND 2134265-2012-01913. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, UNSTABLE ANGINA OCCURRED. IN (B)(6) 2010, THE PATIENT PRESENTED WITH STABLE ANGINA (CCS CLASS-1) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE FIRST, 50% STENOSED, 10 X 3.0 MM, TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX). THE FIRST TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.00 X 12 MM TAXUS LIBERTE STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE SECOND, 70% STENOSED, 14 X 2.75 MM, TARGET LESION WAS LOCATED IN THE 1ST OBTUSE MARGINAL BRANCH (OM). THE SECOND TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 2.75 X 16 MM TAXUS LIBERTE STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. TWO DAYS LATER, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2013, THE PATIENT PRESENTED WITH UNSTABLE ANGINA. THE PATIENT WAS HOSPITALIZED ON THE SAME DAY AND REFERRED FOR CARDIAC CATHETERIZATION. AT THE TIME OF EVENT, THE SUBJECT WAS TAKING ASPIRIN AND CLOPIDOGREL. THE PATIENT WAS NOT ADMINISTERED STUDY DRUG PER PROTOCOL. THE NEXT DAY, THE DISTAL LCX WAS TREATED WITH PLACEMENT OF A 3.00 X 32 MM PROMUS ELEMENT STENT. FOLLOWING STENT PLACEMENT, THERE WAS A "RECURRENT HAZINESS" NOTED IN OSTIUM OF 1ST OM. THE 80% STENOSIS AND HAZINESS IN 1ST OM WERE THEN TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 4.00 X 12 MM PROMUS ELEMENT STENT. THIS RESULTED IN JAILING OF A "PORTION OF THE DISTAL CIRCUMFLEX ARTERY" WHICH WAS TREATED WITH KISSING BALLOON ANGIOPLASTY WITH 0% RESIDUAL STENOSIS. IN ADDITION, 80% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WAS TREATED WITH PLACEMENT OF A 2.50 X 24 MM PROMUS ELEMENT STENT WITH 0% RESIDUAL STENOSIS. AFTER THE PLACEMENT OF THIS STENT, "PERSISTENT APICAL NARROWING WAS PRESENT" WHICH WAS TREATED WITH BALLOON INFLATIONS USING A 2.25 X 15 MM EMERGE BALLOON. RECOIL WAS NOTICED ALONG WITH JAILING OF THE DIAGONAL VESSEL. THE RECOIL WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 2.25 X 16 MM PROMUS ELEMENT STENT IN DISTAL LAD, WITH 0% RESIDUAL STENOSIS. THE JAILED DIAGONAL VESSEL WAS ATTEMPTED TO BE CROSSED USING A CHOICE PT WIRE AND 2.5 X 12 MM EMERGE BALLOON. THE ATTEMPTS WERE UNSUCCESSFUL AND IT WAS DECIDED THE PATIENT WOULD BE TREATED MEDICALLY. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED THE SAME DAY ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95640 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893612300 13541838

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R