BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2905049 · Received January 9, 2013

    Report

    Report Number
    2134265-2012-08327
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 24, 2011
    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

    DEVICE IS A COMBINATION PRODUCT.(B)(4). 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. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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)(6) CLINICAL STUDY. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION. IN (B)(6) 2010, THE PATIENT PRESENTED WITH STABLE ANGINA. THE TARGET LESION WAS A LONG BIFURCATION LESION LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA) EXTENDING INTO THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS 90% STENOSED, 4.0MM IN DIAMETER AND 10MM LONG. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 4.0X12MM TAXUS LIBERTE STENT. FOLLOWING POST DILATION USING KISSING BALLOON TECHNIQUE, RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2011, THE PATIENT PRESENTED WITH VENTRICULAR FIBRILLATION AND WAS HOSPITALIZED ON THE SAME DAY. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECT AND THE PATIENT WAS DISCHARGED THREE DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12544 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893612400 0013170933

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization