BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1701032 · Received May 27, 2010

    Report

    Report Number
    2134265-2010-02382
    Event Type
    Death
    Date Received
    May 27, 2010
    Date of Event
    May 3, 2010
    Report Date
    May 4, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B) (4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. FOUR DAYS POST PROCEDURE, THE PATIENT SUBSEQUENTLY EXPIRED. THE LESION WAS LOCATED AT A BIFURCATION OF THE LEFT MAIN ARTERY TO RAMUS ARTERY. ACCESS WAS FEMORAL. THE PHYSICIAN ADVANCED A 3.00X32MM TAXUS LIBERTE¿ DRUG ELUTING STENT TO THE LESION, HOWEVER; THE PHYSICIAN WAS HAVING POSITIONING DIFFICULTIES DUE THE PATIENT¿S HEARTBEAT CAUSING EXCESSIVE MOVEMENT OF THE DEVICES. THE 3.00X32MM TAXUS LIBERTE¿ DRUG ELUTING STENT MOVED PROXIMAL, WIRE POSITION WAS LOST AND THE GUIDE CATHETER CAME OUT OF THE LEFT MAIN ARTERY CAUSING THE 3.00X32MM TAXUS LIBERTE¿ DRUG ELUTING STENT TO DISLODGE. THE STENT DELIVERY SYSTEM, GUIDEWIRE AND GUIDE CATHETER WERE REMOVED. A NEW GUIDE CATHETER AND GUIDEWIRE WERE USED AND A 3.00X28MM TAXUS LIBERTE¿ DRUG ELUTING STENT WAS ADVANCED TO THE LESION AND DEPLOYED. THE DISLODGED STENT COULD NOT BE LOCATED. NO FURTHER PATIENT INJURIES OR COMPLICATIONS OCCURRED. PATIENT'S STATUS WAS LISTED AS ¿SATISFACTORY.¿ THE PROCEDURE WAS COMPLETED AT THIS TIME AND THE PATIENT WAS SCHEDULED FOR ELECTIVE SURGERY. PRIOR TO THE ELECTIVE PROCEDURE, PLAVIX WAS STOPPED. FOUR DAYS POST STENTING PROCEDURE, THE PATIENT WAS SENT FOR AN ELECTIVE BYPASS PROCEDURE. THE PATIENT WENT INTO CARDIAC ARREST ON THE WAY TO THE OPERATING ROOM AND COULD NOT BE WEANED OFF THE HEART/LUNG BYPASS MACHINE. SHORTLY AFTER THE COMPLETION OF THE BYPASS PROCEDURE, THE PATIENT EXPIRED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    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 H7493893732300 0012789882

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R