BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2810068 · Received October 31, 2012

    Report

    Report Number
    2134265-2012-06524
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    July 2, 2012
    Report Date
    October 2, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MDR#2134265-2012-06521. SAME PATIENT AS MDR#2134265-2010-04899 AND MDR#2134265-2010-04924. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, A MYOCARDIAL INFARCTION (MI) AND CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY OCCURRED. IN (B)(6) 2010, THE PATIENT PRESENTED WITH CONGESTIVE HEART FAILURE. ELEVEN DAYS LATER, THORACIC ECHOCARDIOGRAM REVEALED LEFT VENTRICULAR HYPERTROPHY WITH MILD MITRAL INSUFFICIENCY AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 80% STENOSED, 62MM X 2.75MM, TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND EXTENDING TO THE MID LAD. THE TARGET LESION WAS TREATED SIX DAYS LATER WITH PRE-DILATATION AND PLACEMENT OF A 2.75 X 38 MM TAXUS LIBERTE STENT IN THE MID LAD, FOLLOWED BY OVERLAPPING PLACEMENT OF A 2.75 X 28 MM TAXUS LIBERTE STENT IN THE PROXIMAL LAD. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. DURING THE PROCEDURE, THE 1ST DIAGONAL WAS TREATED WITH BALLOON ANGIOPLASTY RESULTING IN 20% RESIDUAL STENOSIS.; THE 2ND DIAGONAL WAS TREATED WITH CUTTING BALLOON ANGIOPLASTY, RESULTING IN 0% RESIDUAL STENOSIS. THREE DAYS LATER THE SUBJECT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2012, THE PATIENT PRESENTED WITH WORSENING APPEARANCE OF RIGHT FOOT WOUNDS, FEVER, CHILLS, NAUSEA AND VOMITING, AND WAS HOSPITALIZED THE NEXT DAY. BLOOD CULTURES INDICATED GRAM POSITIVE COCCI IN CLUSTERS AND THE SUBJECT WAS DIAGNOSED WITH SEPSIS. DURING THE SAME HOSPITALIZATION, THE SUBJECT EXPERIENCED MID-STERNAL CHEST PRESSURE ASSOCIATED WITH SHORTNESS OF BREATH AND ORTHOPNEA. A CHEST X-RAY REVEALED RIGHT UPPER LOBE OPACIFICATION AND AN ELECTROCARDIOGRAM REVEALED SINUS TACHYCARDIA WITH WIDESPREAD ST SEGMENT DEPRESSION. CARDIAC ENZYMES WERE ELEVATED AND THE PATIENT WAS DIAGNOSED WITH NON ST ELEVATION MYOCARDIAL INFARCTION WHICH WAS MANAGED MEDICALLY. AT THE TIME OF EVENT, THE SUBJECT WAS TAKING ASPIRIN ONLY AS THE STUDY MEDICATION HAD BEEN DISCONTINUED IN MID-JUNE. FIVE DAYS LATER, A NUCLEAR STRESS TEST REVEALED DIFFUSE HYPOKINESIS WITH LEFT VENTRICULAR ENLARGEMENT AND EF 26%, CONSISTENT WITH CARDIOMYOPATHY. CARDIAC CATHETERIZATION WAS RECOMMENDED. FOUR DAYS LATER, THE EVENTS OF SEPSIS, NSTEMI, AND COMMUNITY ACQUIRED PNEUMONIA WERE CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN. IN (B)(6) 2012, THE PATIENT WAS RE-ADMITTED FOR IV DIURESIS. THE NEXT DAY THE PATIENT UNDERWENT 3 VESSEL CABG WITH LEFT INTERNAL MAMMARY ARTERY TO LAD, SAPHENOUS VEIN GRAFT (SVG) TO OBTUSE MARGINAL BRANCH AND SVG TO RIGHT CORONARY ARTERY. THE PATIENT WAS DISCHARGED SIX DAYS LATER ON ASPIRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893628270 13097163

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R