BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 4220939 · Received November 3, 2014

    Report

    Report Number
    2134265-2014-06848
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. 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

    SAME CASE AS MDR ID 2134265-2014-06515. (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT TARGET VESSEL REVASCULARIZATION (TVR) OCCURRED. IN (B)(6) 2010, THE PATIENT PRESENTED WITH A TWO-WEEK HISTORY OF CHEST DISCOMFORT. NUCLEAR STRESS TEST WAS POSITIVE FOR REVERSIBLE INFERIOR WALL ISCHEMIA. THE PATIENT WAS DIAGNOSED WITH STABLE ANGINA AND CARDIAC CATHETERIZATION WAS RECOMMENDED. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WERE PERFORMED. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE 1ST DIAGONAL (D1) WITH 90% STENOSIS AND WAS 14 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. IT WAS TREATED WITH PRE-DILATATION FOLLOWED BY PLACEMENT OF A 16 X 3.00MM TAXUS® LIBERTÉ® STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2014, THE PATIENT PRESENTED WITH ACUTE MYOCARDIAL INFARCTION (MI) AND A 3.00 X 20MM PROMUS PREMIER¿ DRUG ELUTING STENT WAS DEPLOYED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY EXTENDING TO D1. IN (B)(6) 2014, THE PATIENT PRESENTED WITH SYMPTOMS OF UNSTABLE ANGINA AND CARDIAC CATHETERIZATION WAS RECOMMENDED. AT THE TIME OF THE EVENT, THE SUBJECT WAS ON ASPIRIN AND CLOPIDOGREL. THE STUDY DRUG WAS LAST TAKEN IN (B)(6) 2013. SUBSEQUENTLY, CORONARY ANGIOGRAPHY WAS PERFORMED AND REVEALED 80% STENOSIS IN MID LAD AND 90% ISR OSTIUM OF THE D1 OF THE PREVIOUSLY PLACED 3.00 X 20MM PROMUS PREMIER¿ STENT. THE STUDY STENT IN THE D1 WAS PATENT. THE PROXIMAL LAD AND EXTENDING INTO 1ST DIAGONAL WAS TREATED WITH CUTTING BALLOON ANGIOPLASTY, RESULTING IN 0% RESIDUAL STENOSIS. AT THE TIME OF REPORTING, THE EVENT WAS CONSIDERED RECOVERING/ RESOLVING. ASPIRIN AND OTHER ANTIPLATELET MEDICATIONS WERE RECOMMENDED FOR ANOTHER SIX MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704108 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893616300 12903807

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention