BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2981634 · Received February 27, 2013

    Report

    Report Number
    2134265-2013-01007
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    September 22, 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
    MI, 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# 2134265-2013-01005 AND 2134265-2013-01006. SAME PATIENT AS MDR# 2134265-2011-03281 AND 2134265-2011-03301. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, STENT THROMBOSIS OCCURRED. IN (B)(6) 2010, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION IIIB) AND NON-Q WAVE NON-ST ELEVATION MYOCARDIAL INFARCTION (MI) (KILLIP CLASSIFICATION: 1). CARDIAC CATHETERIZATION REVEALED TWO TARGET LESIONS. THE FIRST, 99% STENOSED, 20 X 2.25 MM, TARGET LESION WAS A LONG LESION WITH "POSSIBLE THROMBUS" LOCATED IN THE FIRST OBTUSE MARGINAL CORONARY ARTERY (OM1). THE FIRST TARGET LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.25 X 32 MM TAXUS LIBERTE STENT IMPLANTED "DISTAL TO ALL STENTS PREVIOUSLY PLACED" AND NOT OVERLAPPING ANY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 10%. THE SECOND, 99% STENOSED, 'POSSIBLE THROMBUS', 12 X 2.5 MM, TARGET LESION WAS LOCATED IN THE OM1. THE SECOND TARGET LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.25 X 16 MM TAXUS LIBERTE STENT WITH 0% RESIDUAL STENOSIS. THE THROMBUS WAS SEEN EVEN AFTER THE STENT DEPLOYMENT. NO TIMI DEGRADATION WAS NOTED. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. IN (B)(6) 2011, THE PATIENT PRESENTED WITH CHEST PAIN WITH ISCHEMIC SYMPTOMS AT REST AND ISCHEMIC ELECTROCARDIOGRAM CHANGES SUGGESTIVE OF ACUTE ISCHEMIA. CARDIAC ENZYMES CONSISTED OF A PEAK TROPONIN OF 6.62 NG/ML AND A PEAK CKMB OF 34 NG/ML. THE PATIENT WAS DIAGNOSED WITH A NON ST ELEVATION MI. CARDIAC CATHETERIZATION PERFORMED ONE DAY LATER REVEALED A SUB TOTALLY OCCLUDED STENT TOWARDS THE DISTAL END OF THE OM1. IT WAS INDICATED THAT THIS WAS STENT THROMBOSIS WHICH APPEARED TO BE WITHIN THE MOST DISTAL PREVIOUSLY PLACED STENT. THE PATIENT UNDERWENT ASPIRATION THROMBECTOMY, BALLOON ANGIOPLASTY, AND PLACEMENT OF A 2.5 X 16 MM ION STENT TO THE OM1 RESULTING IN 0% RESIDUAL STENOSIS AND ADDITIONAL BALLOON ANGIOPLASTY TO TREAT A MORE PROXIMAL 90% LESION RESULTING IN 10% RESIDUAL STENOSIS. THE EVENTS WERE CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED THE NEXT DAY. IN (B)(6) 2012, THE PATIENT PRESENTED WITH RECURRENT CHEST PAIN AND WAS DIAGNOSED WITH AN MI. AT THE TIME OF THE EVENT, THE SUBJECT WAS TAKING ASPIRIN AND CLOPIDOGREL. THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WAS TREATED WITH THE PLACEMENT OF 2.50 X 38 MM NON-BSC DRUG ELUTING STENT WITH 0% RESIDUAL STENOSIS. THE PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) WAS TREATED WITH THE PLACEMENT OF A 2.75 X 38 MM NON-BSC DRUG ELUTING STENT WITH 0% RESIDUAL STENOSIS. THE NEXT DAY, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. THREE DAYS LATER, THE PATIENT PRESENTED WITH RECURRENT ANGINA RADIATING TO THE ARM AND CARDIAC CATHETERIZATION WAS RECOMMENDED. CORONARY ANGIOGRAPHY REVEALED A LARGE CLOT IN THE NEWLY STENTED SEGMENT FROM THE MID TO DISTAL LCX. THE PROXIMAL LCX WAS TREATED WITH BALLOON ANGIOPLASTY, TRANSLUMINAL EXTRACTION ATHERECTOMY, AND CUTTING BALLOON ANGIOPLASTY WITH 0% RESIDUAL STENOSIS. TWO DAYS LATER, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83573 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893616250 13249287

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R