BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3221644 · Received July 11, 2013

    Report

    Report Number
    2134265-2013-04724
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    December 11, 2012
    Report Date
    June 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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

    SAME CASE AS: MDR ID 2134265-2013-04725. (B)(4). IT WAS REPORTED THAT SUBSEQUENT TO A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE THE PATIENT EXPERIENCED CHEST PAIN.   THE PATIENT PRESENTED WITH STABLE ANGINA IN MAY 2010 AND UNDERWENT A CARDIAC CATHETERIZATION PROCEDURE WHICH REVEALED A TARGET LESION 1 DE NOVO AND 90% STENOSED LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH A REFERENCE VESSEL DIAMETER OF 3.2MM AND A LESION LENGTH OF 12.9MM. THE LESION WAS PREDILATED WITH AN UNSPECIFIED BALLOON AND DIRECT STENT PLACEMENT OF 2.75X16MM AND 2.5X20MM TAXUS LIBERTE STENT WAS DEPLOYED, RESULTING IN 0% RESIDUAL STENOSIS. TARGET LESION 2 A 2.3% DE NOVO TARGET LESION WAS LOCATED IN THE 2ND OBTUSE MARGINALIS (OM) WITH A REFERENCE DIAMETER OF 2.3MM AND A LESION LENGTH OF 12MM. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING 2.75 X 16 MM TAXUS LIBERTE STENT WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN AND CLOPIDOGREL.   IN (B)(6) 2012, THE PATIENT RETURNED WITH PROGRESSIVELY WORSENING CHEST PAIN AND DISCOMFORT ASSOCIATED WITH SHORTNESS OF BREATH. CARDIOLITE STRESS TEST PERFORMED REVEALED INFERIOR WALL ISCHEMIA AND WAS HOSPITALIZED. CARDIAC CATHETERIZATION REVEALED THAT THE LAD HAD A PATENT PROXIMAL STENT (STUDY STENT), 30% STENOSIS BEFORE THE STENTED SEGMENT, 80-90% MID STENOSIS AND 70-80% OSTIAL STENOSIS IN THE 1ST DIAGONAL. THREE DAYS POST ADMISSION, THE PHYSICIAN THEN DECIDED TO PERFORM TARGET VESSEL REVASCULARIZATION AND CABG X4 WAS PERFORMED WITH LIMA TO LAD, SVG TO DIAGONAL, SVG TO OM1 AND SVG TO R-PDA. FIVE DAYS POST PROCEDURE, THE EVENT WAS CONSIDERED RESOLVED WITH RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319924 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893716270 13248049

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention