BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3863782 · Received June 10, 2014

    Report

    Report Number
    2134265-2014-03129
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 27, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. IT WAS REPORTED THAT RESTENOSIS OCCURRED. ON (B)(6) 2010, THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION AND INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS A DE-NOVO LESION LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX ) WITH 95% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 X 16 MM TAXUS® LIBERTÉ® STENT. FOLLOWING POS DILATATION, RESIDUAL RESTENOSIS WAS 0%. ONE DAY POST PROCEDURE, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. ON (B)(6) 2014, THE SUBJECT WAS DIAGNOSED WITH WORSENING CORONARY ARTERY DISEASE. ON (B)(6) 2014, THE SUBJECT WAS ALSO DIAGNOSED WITH POST-OPERATIVE ANEMIA AND WAS HOSPITALIZED AND CARDIAC CATHETERIZATION WAS RECOMMENDED. STUDY DRUG PROTOCOL WAS LAST TAKEN IN 2011. CORONARY ARTERY BYPASS (CABG) WAS PERFORMED FROM SAPHENOUS VEIN GRAFT (SVG) TO OBTUSE MARGINAL (OM) WHICH AND LEFT INTERNAL MAMMARY ARTERY (LIMA) TO LEFT ANTERIOR DESCENDING ARTERY (LAD). AT THE TIME OF REPORTING, POST OPERATIVE ANEMIA WAS CONSIDERED TO BE RECOVERING/ RESOLVING. FIVE DAYS POST HOSPITALIZATION, WORSENING CORONARY ARTERY DISEASE WAS CONSIDERED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCHARGED.

    Description of Event or Problem · 1

    SAME CASE AS MDR-ID: 2134265-2014-03866. IT WAS FURTHER REPORTED THAT IN (B)(6) 2010 ANGIOGRAPHY REVEALED 20-30% LCX MID-VESSEL IN-STENT RESTENOSIS OF A PREVIOUSLY IMPLANTED TAXUS STENT IMPLANTED IN (B)(6) 2006. 3.0X16MM TAXUS STUDY STENT WAS IMPLANTED TO COVER THE RE-STENOSED MID-LCX LESION.

    Description of Event or Problem · 1

    SAME CASE AS MDR-ID: 2134265-2014-03866. IT WAS FURTHER REPORTED THAT IN (B)(6) 2010, THE SUBJECT PRESENTED WITH SHORTNESS OF BREATH WITH EXERTION AND STRESS TEST REVEALS LATERAL ISCHEMIA AND INFERIOR FIXED DEFECT. IN (B)(6) 2014, THE SUBJECT PRESENTED WITH CHEST PAIN TO EMERGENCY DEPARTMENT. AT THE TIME OF THE EVENT, THE SUBJECT WAS ON ASPIRIN AND PRASUGREL. IN (B)(6) 2014, CORONARY ANGIOGRAM WAS PERFORMED AND REVEALED SEVERE IN-STENT RESTENOSIS OF THE PREVIOUSLY PLACED STUDY STENT AND THE 3.0MM X 16MM TAXUS NON-STUDY STENT PLACED IN THE MID SEGMENT OF THE LEFT CIRCUMFLEX (LCX).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340961 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893716300 13329386

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R