BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2220740 · Received August 23, 2011

    Report

    Report Number
    2134265-2011-03638
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    November 8, 2010
    Report Date
    July 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    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 COMBINATION PRODUCT. PATIENT IDENTIFIER: (B)(6). 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).

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM, RELEVANT TESTS/LAB DATA: UPDATED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MFR ID#: 2134265-2011-03639. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, MYOCARDIAL INFARCTION OCCURRED. THE PATIENT PRESENTED AT THE TIME OF THE INDEX PROCEDURE DUE TO STABLE ANGINA (CCS CLASS 2). CARDIAC CATHETERIZATION REVEALED 2 TARGET LESIONS. THE FIRST WAS A 99% STENOSED AND 16MM LONG LESION LOCATED IN A SAPHENOUS VEIN GRAFT (SVG) TO THE RAMUS WITH A REFERENCE VESSEL DIAMETER OF 3.5MM. IT WAS TREATED WITH PREDILATION AND DEPLOYMENT OF A 3.5X28MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. THERE WAS TRANSIENT SLOW FLOW AND SLIGHT ST SEGMENT ELEVATION FOLLOWING STENT DEPLOYMENT. THE SECOND LESION WAS LOCATED IN THE NATIVE RAMUS AND WAS 80% STENOSED AND 12MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. IT WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.25X16MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. IMMEDIATELY FOLLOWING THE INDEX PROCEDURE, THE PATIENT COMPLAINED OF CHEST PAIN. 1 DAY LATER, CARDIAC ENZYMES WERE NOTED TO BE ELEVATED AND THE PATIENT WAS DIAGNOSED AS HAVING A MYOCARDIAL INFARCTION (TYPE "4A"). THE PATIENT REMAINED HOSPITALIZED AN EXTRA DAY FOR OBSERVATION AND WAS DISCHARGED 2 DAYS POST INDEX PROCEDURE ON ASPIRIN AND PRASUGREL. THE EVENT IS REPORTED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS. IT IS THE OPINION OF THE PHYSICIAN THAT THIS EVENT IS NOT RELATED TO THE TAXUS LIBERTE STENTS.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT AT THE TIME OF INDEX, SLUGGISH FLOW WAS NOTED IN THE SAPHENOUS VEIN GRAFT (SVG) TO RAMUS GRAFT AFTER PLACEMENT OF 3.50 X 28 MM TAXUS LIBERTE STUDY STENT. THIS WAS TREATED WITH INTRACORONARY NITROGLYCERIN AND INTEGRILIN ADMINISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893628350 12897694

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization