BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 4182100 · Received October 17, 2014

    Report

    Report Number
    2134265-2014-06284
    Event Type
    Death
    Date Received
    October 17, 2014
    Date of Event
    April 28, 2014
    Report Date
    September 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 2134265-2014-06285. (B)(4). IT WAS REPORTED THAT CONGESTIVE HEART FAILURE AND PATIENT DEATH OCCURRED. IN (B)(6) 2010, THE PATIENT PRESENTED DUE TO A 6-MONTH HISTORY OF CHEST PAIN RADIATING TO THE NECK AND ASSOCIATED WITH INCREASING SHORTNESS OF BREATH AND COUGH. THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA, NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION AND CARDIAC CATHETERIZATION WAS RECOMMENDED. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WERE PERFORMED. THE TARGET LESION #1 WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) WITH 70 % STENOSIS AND WAS 25 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE LESION WAS TREATED WITH PRE-DILATATION FOLLOWED BY PLACEMENT OF A 2.50 X 28 MM TAXUS® LIBERTÉ® STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE TARGET LESION #2 WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 70% IN-STENT RESTENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.3 MM. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING 2.25 X 12 MM TAXUS® LIBERTÉ® STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. IN ADDITION, DURING THE PROCEDURE, A NON BSC SINGLE CHAMBER IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) WAS UPDATED TO A NON BSC BIVENTRICULAR ICD. FOUR DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2014, THE PATIENT EXPIRED. AT THE TIME OF THE EVENT, THE PATIENT WAS TAKING ASPIRIN AND PRASUGREL. THE STUDY DRUG WAS LAST TAKEN IN 2011. AS PER DEATH CERTIFICATE DATED (B)(6) 2014, THE CAUSE OF PATIENT'S DEATH WAS END STAGE CONGESTIVE HEART FAILURE. IT WAS NOT KNOWN IF AN AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660755 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893728250 13355636

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death