BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1923839 · Received December 14, 2010

    Report

    Report Number
    2134265-2010-05540
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    October 7, 2010
    Report Date
    November 16, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(4). 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#: 2134265-2010-05541. (B)(4). IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE INCOMPLETE STENT APPOSITION OCCURRED. THE TARGET LESION WAS LOCATED IN THE 1ST OBTUSE MARGINAL (OM) WITH 99% STENOSIS AND WAS 14MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF TWO 2.25MM X16MM TAXUS LIBERTE STENTS AND POST DILATATION WITH 0% RESIDUAL STENOSIS. THE 2ND TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY WITH 80% STENOSIS AND WAS 24MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00MM X 20MM TAXUS LIBERTE STENT AND POST DILATATION WITH 0% RESIDUAL STENOSIS. POST-STENT DEPLOYMENT USE OF IVUS REVEALED INCOMPLETE APPOSITION OF BOTH 2.25X16MM TAXUS LIBERTE STENTS IN THE 1ST OM WHICH WERE TREATED WITH POST DILATATIONS WITH A COMPLIANT BALLOON. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL.

    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 H7493893616220

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention 2.25MM X 16MM TAXUS LIBERTE STENT