BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3000362 · Received March 12, 2013

    Report

    Report Number
    2134265-2013-01338
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    August 5, 2010
    Report Date
    February 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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

    SAME CASE AS MFR ID # 2134265-2013-01400. (B)(4) STUDY. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A VESSEL DISSECTION OCCURRED. THE 2.25X12MM, 90% STENOSED ECCENTRIC TARGET LESION WAS LOCATED IN THE 1ST DIAGONAL (D1) ARTERY BIFURCATION. THE LESION WAS PRE-DILATED AND THE 2.25X12MM TAXUS LIBERTE STENT WAS DEPLOYED, POST-DILATION RESULTED IN 0% RESIDUAL STENOSIS. THE BIFURCATION WAS PRE-DILATED AND THE 2.5X12MM TAXUS LIBERTE STENT WAS DEPLOYED AND POST-DILATED RESULTING IN 0% RESIDUAL STENOSIS. DURING POST-DILATION A GRADE C DISSECTION WAS NOTED. DISSECTION WAS TREATED WITH BALLOON DILATION. A 3.0X24MM, 70% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WAS PRE-DILATED AND THE 3.0X24MM TAXUS LIBERTE STENT WAS DEPLOYED. POST DILATION RESULTED IN 0% RESIDUAL STENOSIS. AT 11 DAYS POST INDEX PROCEDURE PATIENT RETURNED TO CATHERIZATION LAB FOR A STAGED PROCEDURE. A 2.5X40MM, 80% STENOSED TARGET LESION WAS LOCATED IN THE 1ST OBTUSE MARGINAL (OM1) ARTERY. THE LESION WAS PRE-DILATED AND THE 2.5X28MM TAXUS LIBERTE AND 2.25X12MM TAXUS LIBERTE STENTS WERE SUCCESSFULLY DEPLOYED. POST-DILATION RESULTED IN 0% RESIDUAL STENOSIS. PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103484 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893612250 13116903

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention