BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS¿ LIBERTÉ¿

    MDR report key: 2923116 · Received January 18, 2013

    Report

    Report Number
    2134265-2013-00146
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    November 29, 2012
    Report Date
    December 24, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. 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)(6). IT WAS REPORTED THAT SUBSEQUENT TO A STENTING TREATMENT PROCEDURE, STENT RESTENOSIS OCCURRED. THE PATIENT PRESENTED WITH CLASS 2 STABLE ANGINA IN (B)(6) 2012 AND UNDERWENT A CARDIAC CATHETERIZATION PROCEDURE WHICH REVEALED 1 TARGET LESION. THE LESION WAS 90% STENOSED AND LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH A REFERENCE VESSEL DIAMETER OF 3.50 MM AND A LESION LENGTH OF 12 MM. THE LESION WAS PREDILATED WITH AN UNSPECIFIED BALLOON AND A 3.50 X 20 MM TAXUS LIBERTE STENT WAS DEPLOYED, RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED TWO DAYS LATER ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012 THE PATIENT RETURNED AND IN-STENT RESTENOSIS WAS DIAGNOSED. A FEW DAYS LATER, IN (B)(6) 2012 DIAGNOSTIC ANGIOGRAPHY WAS PERFORMED REVEALING 85% IN-STENT RESTENOSIS OF THE LAD WITH TIMI 3 FLOW. AN UNSPECIFIED DRUG ELUTING STENT WAS ADVANCED AND DEPLOYED IN THE PROXIMAL LAD RESULTING IN 0% RESIDUAL STENOSIS AND TIMI 3 FLOW REMAINED. THE EVENT WAS CONSIDERED RESOLVED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27170 TAXUS¿ LIBERTÉ¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894020350 0014289696

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention