BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1884984 · Received October 28, 2010

    Report

    Report Number
    2134265-2010-04787
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    August 19, 2010
    Report Date
    October 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). 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).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MFR ID: 2134265-2010-04786. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. THE PATIENT PRESENTED WITH CHEST PAIN THAT WORSENED ON EXERTION WITH SHORTNESS OF BREATH AND WAS REFERRED FOR CARDIAC CATHETERIZATION WHICH REVEALED 2 LESIONS. THE FIRST WAS AN 80% STENOSED AND 18MM LONG LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH A REFERENCE VESSEL DIAMETER OF 3.5MM. IT WAS TREATED WITH DIRECT STENTING OF A 3.5X20MM TAXUS LIBERTE STENT RESULTING IN 9% RESIDUAL STENOSIS. THE SECOND WAS A 95-99% STENOSED AND 14MM LONG LESION LOCATED IN THE RIGHT POSTERIOR DESCENDING CORONARY ARTERY (PDA) WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. IT WAS TREATED WITH DIRECT STENTING OF A 2.5X16MM TAXUS LIBERTE STENT RESULTING IN 9% RESIDUAL STENOSIS. THE SAME DAY POST PROCEDURE, ELEVATION OF TROPONIN LEVELS WERE REPORTED. 1 DAY POST PROCEDURE, TROPONIN LEVELS HAD INCREASED MORE AND THE PATIENT WAS DIAGNOSED WITH A MYOCARDIAL INFARCTION WITH A PEAK TROPONIN OF 1.52NG/ML. NO TREATMENT WAS PROVIDED. THE PATIENT'S HOSPITALIZATION STAY WAS EXTENDED BY ONE DAY DUE TO THE EVENT. THE EVENT WAS REPORTED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED 2 DAYS FOLLOWING THE INDEX PROCEDURE ON ASPIRIN AND PRASUGREL. IT IS THE OPINION OF THE PHYSICIAN THAT THIS EVENT IS UNRELATED TO THE TAXUS LIBERTE STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893716250 13120684

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization 3.5X20MM TAXUS LIBERTE STENT