BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 1954962 · Received January 10, 2011

    Report

    Report Number
    2134265-2010-05956
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 22, 2010
    Report Date
    December 14, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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)

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    (B)(6) STUDY. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, RESTENOSIS OCCURRED. DUE TO STABLE ANGINA (CCS CLASS I), THE PATIENT UNDERWENT CARDIAC CATHETERIZATION WHICH REVEALED 2 TARGET LESIONS. THE FIRST WAS A 99% STENOSED AND 8MM LONG LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. IT WAS TREATED WITH PRE-DILATION AND A 2.25X12MM TAXUS LIBERTE STENT WAS IMPLANTED RESULTING IN 9% RESIDUAL STENOSIS. THE SECOND WAS AN 80% STENOSED AND 4MM LONG LESION LOCATED IN THE PROXIMAL LAD WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. IT WAS TREATED WITH DIRECT STENT PLACEMENT OF A 2.5X8MM TAXUS LIBERTE STENT FOLLOWED BY POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND PRASUGREL. (B)(6) - 2010: THE PATIENT DEVELOPED CARDIAC CHEST PAIN AND SUBSEQUENTLY UNDERWENT CARDIAC CATHETERIZATION WHICH REVEALED IN STENT RESTENOSIS OF THE 2.5X8MM TAXUS LIBERTE STENT THAT WAS PREVIOUSLY IMPLANTED IN THE PROXIMAL LAD. THE RESTENOSIS WAS LOCATED ON THE PROXIMAL EDGE OF THE STENT. IT WAS TREATED WITH A CUTTING BALLOON AND A DRUG ELUTING STENT WAS IMPLANTED RESULTING IN 0% RESIDUAL STENOSIS AND TIMI-3 FLOW. THE EVENT WAS REPORTED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND PRASUGREL. IT IS THE OPINION OF THE PHYSICIAN THAT THE EVENT IS RELATED TO THE 2.5X8MM (B)(6) STUDY STENT, BUT IS UNRELATED TO THE 2.25X12MM TAXUS LIBERTE STUDY STENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT PRESENTED WITH CHEST PAIN IN (B)(6) 2010. THE LEFT MAIN/PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WAS REVASCULARIZED WITH A CUTTING BALLOON AND A 3.5MM X 20MM TAXUS LIBERTE STENT. POST TREATMENT TIMI FLOW WAS 3 AND RESIDUAL STENOSIS WAS 0%. THE EVENT WAS CONSIDERED RESOLVED THE SAME DAY. THE PATIENT WAS DISCHARGED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H749389368250 13329384

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R 2.25 MM X 12 MM TAXUS LIBERTE STENT