BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTE' OTW CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1153197 · Received September 5, 2008

    Report

    Report Number
    2134265-2008-02554
    Event Type
    Death
    Date Received
    September 5, 2008
    Date of Event
    February 14, 2008
    Report Date
    September 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2008-02552, 2134265-2008-02555 AND 2134265-2008-02553. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, A THROMBOSIS AND DEATH OCCURRED. THE PHYSICIAN PLACED FOUR TAXUS LIBERTE' BARE METAL STENTS TO THE 70-80% STENOSED LESION LOCATED IN THE CALCIFIED PROXIMAL TO DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) DUE TO A NON ST ELEVATION MYOCARDIAL INFARCTION (MI). A 3.0X20MM LIBERTE' WAS PLACED IN THE DISTAL LAD AFTER PRE-DILATATION WITH A MAVERICK 2.5X15MM BALLOON. A 3.0X24MM LIBERTE' WAS THEN DEPLOYED AT 18 ATMS FOR 30 SECONDS. POST DILATATION WAS PERFORMED AT 18-24 ATMS. A LIBERTE' 3.5X32MM STENT WAS THEN DEPLOYED AT 14 ATMS FOR 30 SECONDS, FOLLOWED BY THE PLACEMENT OF A LIBERTE' 3.5X24MM STENT, DEPLOYED AT 16 ATMS FOR 30 SECONDS AND POST DILATED AT 24 ATMS FOR 15 SECONDS. RESIDUAL STENOSIS WAS 0%. PLAVIX AND ASPIRIN WERE PRESCRIBED POST PROCEDURE. NITROGLYCERIN AND HEPARIN WERE ADMINISTERED DURING THIS PROCEDURE. NO ADDITIONAL PT INJURIES OR COMPLICATIONS WERE REPORTED. THREE DAYS POST PROCEDURE THE PT PRESENTED WITH AN ACUTE ST ELEVATION MI AND THROMBUS IN THE LAD. THE PHYSICIAN USED A MAVERICK 3.0X20MM BALLOON FOR SERIAL INFLATIONS AT 20 ATMS, BUT FLOW WAS NOT RESTORED. AN ANGIO-JET CATHETER WAS ADVANCED WITH NO SUCCESS, FOLLOWED BY INFLATIONS OF THE MAVERICK BALLOON, BUT MULTIPLE ATTEMPTS TO RESTORE FLOW WERE UNSUCCESSFUL AND THE PT WENT IN TO CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION WAS PERFORMED AND EPINEPHRINE WAS ADMINISTERED. THE PT WAS PRONOUNCED DEAD APPROX 10 MINS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' OTW CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC CORPORATION NA 9325459

    Patients

    Seq Age Sex Outcome Treatment
    1 Death