BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2022671 · Received March 17, 2011

    Report

    Report Number
    2134265-2011-00786
    Event Type
    Death
    Date Received
    March 17, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCTDEVICE EVALUATED BY MANUFACTURER - THE COMPLAINT DEVICE WAS NOT RECEIVED 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)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PHYSICIAN USED A DEFIBRILLATOR, ANTI-ARRHYTHMIC DRUG, AND 'BOOST PRESSURE' DRUG IN RESPONSE TO THE VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION. THE DOCUMENTED CAUSE OF DEATH IS REPORTED AS VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION. THE PHYSICIAN DOES NOT FELL THE TAXUS LIBERTE STENTS ARE RELATED TO THE PATIENTS DEATH.

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2011-00787. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, AN ANEURYSM OCCURRED AND POST PROCEDURE THE PATIENT DIED. THE PATIENT PRESENTED WITH UNSTABLE ANGINA. VASCULAR ACCESS WAS OBTAINED THROUGH THE RADIAL ARTERY. THE 70-90% STENOSED, 5-6MM IN DIAMETER AND 15-20MM IN LENGTH, DE NOVO AND ECCENTRIC LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED MID TO DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION CONTAINED A >45 TO <90 DEGREE BEND. THE LESION WAS NOT PREDILATED DUE TO THE LARGE DIAMETER OF THE VESSEL. AFTER THE PHYSICIAN IMPLANTED A 5.0X24MM TAXUS LIBERTE STENT, AN ANEURYSM WAS FOUND IN THE PROXIMAL PORTION OF THE VESSEL. THE 5.0X24MM STENT WAS NOT WELL APPOSED TO THE VESSEL WALL AND SLOW BLOOD FLOW FORMED, TIMI FLOW WAS 0. THE PHYSICIAN USED 2.50X20MM NON-BSC BALLOON TO DILATE THE STENT AND THE LESION IN MID RCA. A 5.0X20MM TAXUS LIBERTE STENT WAS IMPLANTED IN THE MID RCA. TIMI FLOW 1 TO 2 WAS ACHIEVED. A TEMPORARY PACEMAKER WAS PLACED BEFORE ENDING THE PROCEDURE. FOUR HOURS POST THE PROCEDURE, THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION. RESCUE EFFORTS WERE PERFORMED, BUT THE PATIENT DIED 2 HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493894024500 13835899

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death RUNTHROUGH GUIDE WIRE| CHOICE PT GUIDE WIRE