BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 4171077 · Received October 14, 2014

    Report

    Report Number
    2134265-2014-06116
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 14, 2014
    Report Date
    September 18, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A 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 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)(6). (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT ANGINA AND IN-STENT RESTENOSIS (ISR) OCCURRED. IN (B)(6) 2010, THE PATIENT PRESENTED WITH COMPLAINTS OF FATIGUE, EXERTIONAL DYSPNEA, AND MILD CHEST DISCOMFORT. STRESS TEST WAS FOUND TO BE ABNORMAL. THE PATIENT WAS DIAGNOSED WITH STABLE ANGINA AND CARDIAC CATHETERIZATION WAS RECOMMENDED. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WERE PERFORMED. THE TARGET LESION #1 WAS LOCATED IN THE OSTIAL/PROXIMAL PORTION OF SAPHENOUS VEIN GRAFT (SVG) TO RIGHT POSTERIOR DESCENDING ARTERY (R-PDA) WITH 80% STENOSIS AND WAS 14.00 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.50 MM. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.50 X 20 MM TAXUS® LIBERTÉ® STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE TARGET LESION #2 WAS A LONG LESION LOCATED IN THE DISTAL LEFT MAIN CORONARY ARTERY (LMCA) AND EXTENDING TO THE OSTIAL/PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 75% STENOSIS AND WAS 14.00 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.50 MM. IT WAS TREATED WITH ROTATIONAL ATHERECTOMY, PRE-DILATATION AND PLACEMENT OF A 3.00 X 20 MM TAXUS® LIBERTÉ® STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2013, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND A 3.5 X 20 MM PROMUS ELEMENT PLUS DRUG ELUTING STENT WAS IMPLANTED IN THE SVG TO R-PDA. IN (B)(6) 2014, THE PATIENT PRESENTED WITH SUBSTERNAL CHEST PRESSURE THAT RADIATED TO THE BACK AND DOWN TO THE LEFT ARM AND WAS ASSOCIATED WITH NAUSEA AND SHORTNESS OF BREATH. THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA AND WAS HOSPITALIZED. CARDIAC CATHETERIZATION WAS RECOMMENDED. AT THE TIME OF EVENT, THE PATIENT WAS TAKING ASPIRIN AND CLOPIDOGREL. THE STUDY DRUG WAS LAST TAKEN IN (B)(6) 2012. CORONARY ANGIOGRAPHY WAS PERFORMED AND REVEALED 75-80% PROXIMAL ISR OF THE PREVIOUSLY PLACED 3.5 X 20 MM STUDY STENT AND THE 3.5 X 20 MM PROMUS ELEMENT PLUS STENT LOCATED IN THE PROXIMAL PART OF THE SVG TO R-PDA. IT WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 3.5 X 16 MM PROMUS PREMIER STENT RESULTING IN 15-20% RESIDUAL STENOSIS. FIFTEEN DAYS POST PROCEDURE, THE EVENT WAS CONSIDERED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651869 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893620350 13162350

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R