BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2945700 · Received February 6, 2013

    Report

    Report Number
    2134265-2013-00500
    Event Type
    Death
    Date Received
    February 6, 2013
    Date of Event
    December 10, 2010
    Report Date
    January 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. PATIENT IDENTIFIER: (B)(6). 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 BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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) STUDY. SAME CASE AS MDR ID# 2134265-2012-08021. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION AND LATER EXPIRED. INDEX PROCEDURE. (B)(6) 2010 - THE PATIENT PRESENTED WITH PERSISTENT EXERTIONAL ANGINA SYMPTOMS AND WAS DIAGNOSED WITH STABLE ANGINA. THE 100% STENOSED DE NOVO TARGET LESION WAS 45MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM, LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY EXTENDING INTO THE MID LAD. THE PHYSICIAN ADVANCED A 2.5 X 32MM TAXUS LIBERTE TO THE PROXIMAL LAD AND ATTEMPTED TO DEPLOY BUT WAS UNSUCCESSFUL. THE STENT WAS REMOVED. THE PHYSICIAN THEN PRE DILATED THE LESION AND PLACED TWO STENTS OVERLAPPING, A 2.25 X 32MM TAXUS LIBERTE AND A 2.25 X 32MM TAXUS LIBERTE, RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. (B)(6) 2012 - THE PATIENT PRESENTED WITH ANTERIOR CHEST PAIN ASSOCIATED WITH DIAPHORESIS AND NAUSEA. PATIENT WAS TAKEN TO THE EMERGENCY DEPARTMENT WERE AN EKG REVEALED AN ACUTE ANTERIOR MYOCARDIAL INFARCTION. A REPEAT EKG REVEALED A WIDE COMPLEX RHYTHM AND RIGHT BUNDLE BLOCK WITH SINUS. THE CARDIAC MONITOR INITIALLY REVEALED WIDE COMPLEX TACHYCARDIA WHICH DETERIORATED INTO VENTRICULAR FIBRILLATION. THE PATIENT UNDERWENT CPR WITH IV EPINEPHRINE, ATROPINE, AMIODARONE, CALCIUM CHLORIDE AND DEFIBRILLATED MULTIPLE TIMES DUE TO DETERIORATION OF RHYTHM TO VENTRICULAR FIBRILLATION. THE PATIENT WAS INTUBATED AND SUBSEQUENTLY FOUND TO BE IN PULSELESS ELECTRICAL ACTIVITY WITH NO BLOOD PRESSURE RETURN DESPITE AGGRESSIVE ADVANCED CARDIAC LIFE SUPPORT PROTOCOLS. THE PATIENT EXPIRED THE SAME DAY. AT THE TIME OF THE EVENT, THE PATIENT WAS TAKING ASPIRIN. STUDY MEDICATION WAS DISCONTINUED (B)(6) 2012. THE CAUSE OF DEATH WAS ACUTE ANTERIOR MYOCARDIAL INFARCTION.

    Description of Event or Problem · 1

    THE (B)(6) HAS DETERMINED THERE IS EVIDENCE OF STENT THROMBOSIS DURING THE (B)(6) 2012 PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51170 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death