BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 4111157 · Received September 23, 2014

    Report

    Report Number
    2134265-2014-05658
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    July 25, 2014
    Report Date
    September 1, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    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

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED 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) CLINICAL STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS (ISR) AND MYOCARDIAL INFARCTION (MI) OCCURRED. IN (B)(6) 2010, THE SUBJECT PRESENTED DUE TO A POSITIVE STRESS TEST AND WAS DIAGNOSED WITH STABLE ANGINA. CARDIAC CATHETERIZATION WAS RECOMMENDED. CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WERE PERFORMED. TARGET LESION #1 WAS A DE NOVO LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 2.50 X 16 MM TAXUS® LIBERTÉ® STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. ONE DAY POST INDEX PROCEDURE, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2014, THE SUBJECT PRESENTED WITH COMPLAINTS OF CHEST PAIN. THE FOLLOWING DAY, ELECTROCARDIOGRAM (ECG) WAS TAKEN AND REVEALED BORDERLINE PROLONGED PULSE RATE (PR) INTERVAL, PROBABLE LEFT ATRIAL ENLARGEMENT, LEFT VENTRICULAR HYPERTROPHY (LVH) WITH SECONDARY ABNORMALITY AND AGE DETERMINATE INFERIOR INFARCT. TROPONIN I WAS ALSO FOUND TO BE ELEVATED. THE SUBJECT WAS DIAGNOSED WITH NON ST ELEVATION MI AND CARDIAC CATHETERIZATION WAS RECOMMENDED. AT THE TIME OF EVENT, THE SUBJECT WAS TAKING ASPIRIN AND CLOPIDOGREL. THE STUDY DRUG PER PROTOCOL WAS LAST TAKEN IN (B)(6) 2012. THREE DAYS FROM THE ONSET OF SYMPTOMS, CORONARY ANGIOGRAPHY WAS PERFORMED AND REVEALED 100% TOTALLY OCCLUDED ISR OF THE PREVIOUSLY PLACED STUDY STENT LOCATED IN THE DISTAL RCA. IT WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 2.25 X 28 MM NON BSC STENT WITH 0% RESIDUAL STENOSIS. IN ADDITION, THE 100% OCCLUSION IN THE PROXIMAL AND MID RCA WERE TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF 2.75 X 23 MM AND 3.0 X 15 MM NON BSC STENTS RESPECTIVELY, WITH 0% RESIDUAL STENOSIS. ONE DAY POST PROCEDURE, THE EVENTS WERE CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592652 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893616250 12350940

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R