BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2905116 · Received January 9, 2013

    Report

    Report Number
    2134265-2012-08350
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    November 16, 2012
    Report Date
    December 13, 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 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. THE MANUFACTURING BATCH RECORD REVIEW CONFORMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION AS THE REPORTED EVENT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE PRODUCT DIRECTIONS FOR USE (DFU) AND/OR DEVICE LABELING. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT HAD SUBACUTE CORONARY SYNDROME. IN (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH STABLE ANGINA (CCS CLASS 2) AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE DE NOVO TARGET LESION WAS LOCATED IN THE 1ST OBTUSE MARGINAL BRANCH (OM1) WITH 80% OSTIAL STENOSIS AND WAS 8MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT PLACEMENT OF A 3.00X12MM TAXUS LIBERTE STENT, WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6)2012, THE PATIENT WAS DIAGNOSED WITH ALTERED MENTAL STATUS AND SUSPECTED SUBACUTE CORONARY SYNDROME. THE PATIENT WAS HOSPITALIZED AND CARDIAC MEDICATIONS WERE ADMINISTERED. THE EVENT WAS CONSIDERED AS RESOLVED WITH RESIDUAL EFFECTS. IN THE OPINION OF THE PHYSICIAN, THE EVENT OF ALTERED MENTAL STATUS WAS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12915 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893612300 13073499

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R