BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3013090 · Received March 20, 2013

    Report

    Report Number
    2134265-2013-01656
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    December 28, 2011
    Report Date
    February 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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). SAME CASE AS MDR ID# 2134265-2013-01655. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, A MYOCARDIAL INFARCTION OCCURRED. INDEX PROCEDURE: (B)(6) 2010 - THE PATIENT HAD TWO TARGET LESIONS. TARGET LESION #1 WAS LOCATED IN THE MID LAD WITH 80% STENOSIS AND WAS 6 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM WHICH WAS TREATED WITH PRE DILATATION AND PLACEMENT OF A 2.50 X 12 MM TAXUS LIBERTE STENT, WITH 0% RESIDUAL STENOSIS. TARGET LESION #2 WAS LOCATED IN THE MID LAD WITH 60% STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM WHICH WAS TREATED WITH PRE DILATATION AND PLACEMENT OF A 2.50 X 8 MM TAXUS LIBERTE STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. (B)(6) 2011 - THE PATIENT PRESENTED FOR EVALUATION OF SEVERE AORTIC STENOSIS WITH RECURRENT CORONARY ARTERY DISEASE. THE PATIENT WAS DIAGNOSED WITH MYOCARDIAL INFARCTION AND WAS HOSPITALIZED ON THE SAME DAY. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN AND STUDY DRUG, WHICH WAS DISCONTINUED. A TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS PERFORMED AND REVEALED THE AORTIC VALVE TO BE SEVERELY CALCIFIED WITH VERY POOR EXCURSION. THERE WAS SIGNIFICANT TURBULENT FLOW ACROSS THE VALVE. THERE WAS 2+ AORTIC INSUFFICIENCY NOTED. THERE WAS 1-2+ MITRAL REGURGITATION NOTED WITH THICKENING OF THE MITRAL LEAFLETS. LEFT VENTRICULAR HYPERTROPHY WAS NOTED WITH SOME MILD DILATATION OF THE LEFT VENTRICULAR CAVITY. (B)(6) 2012 - THE PATIENT WAS DIAGNOSED WITH AORTIC VALVE STENOSIS AND REFERRED FOR CABG AND AORTIC VALVE REPLACEMENT. THE NEXT DAY THE PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT (CABG) LEFT INTERNAL MAMMARY ARTERY (LIMA) TO THE LEFT ANTERIOR DESCENDING ARTERY (LAD). IN ADDITION AN AORTIC VALVE REPLACEMENT WAS ALSO PERFORMED. FOUR DAYS LATER THE EVENT OF AORTIC VALVE STENOSIS WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THE TWO TARGET LESIONS INITIALLY TREATED WERE DE NOVO LESIONS, THE PATIENT WAS DIAGNOSED WITH A NON Q-WAVE MI, AND DIAGNOSTIC CARDIAC CATH PERFORMED (B)(6) 2011, REVEALED 'MILD DISTAL IN-STENT RESTENOSIS'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115016 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H749389368250 13340963

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R