BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2863198 · Received December 10, 2012

    Report

    Report Number
    2134265-2012-07243
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    June 6, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATION. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, WORSENING CORONARY ARTERY DISEASE OCCURRED. IN (B)(6) 2010, THE PATIENT PRESENTED WITH SUBSTERNAL UPPER CHEST DISCOMFORT AND WAS DIAGNOSED WITH STABLE ANGINA. CARDIAC CATHETERIZATION WAS RECOMMENDED. THE FIRST TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY AND WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 16 MM TAXUS LIBERTE STENT, WITH 10% RESIDUAL STENOSIS. THE SECOND, 10MM X 2.50MM, 80% STENOSED TARGET LESION WAS LOCATED IN THE DISTAL LEFT CIRCUMFLEX ARTERY (LCX). THE SECOND TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 12 MM TAXUS LIBERTE STENT, WITH 0% RESIDUAL STENOSIS. THE THIRD TARGET LESION WAS LOCATED IN THE 1ST DIAGONAL AND WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 24 MM TAXUS LIBERTE STENT, WITH 0% RESIDUAL STENOSIS. TWO DAYS LATER, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2012, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND FATIGUE. THE PATIENT WAS DIAGNOSED WITH WORSENING CORONARY ARTERY DISEASE AND WAS HOSPITALIZED. THE 80% STENOSIS PRIOR TO BIFURCATION OF LCX WITH THE OBTUSE MARGINAL OM) BRANCH WAS TREATED WITH PLACEMENT OF A 3.00 X 18 MM NON-BSC STENT, WITH 0% RESIDUAL STENOSIS. THE STENOSIS IN THE 2ND OM WAS TREATED WITH PLACEMENT OF A AND 2.75 X 28 MM NON-BSC STENT, WITH 0% STENOSIS. TWO DAYS LATER, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND PLAVIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893612250 0013077534

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Required Intervention