BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1153194 · Received September 5, 2008

    Report

    Report Number
    2134265-2008-02550
    Event Type
    Death
    Date Received
    September 5, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    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

    IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PT PRESENTED WITH THROMBOSIS AND THE PT DIED. THE PT PRESENTED WITH AN ACUTE ST ELEVATED MYOCARDIAL INFARCTION. THE 80-90% STENOSED LESION BEING TREATED WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE 95% STENOSED PROXIMAL CIRCUMFLEX (CX). THE LESIONS WERE NOT PREDILATED. THE PHYSICIAN DEPLOYED A 3.0X12MM LIBERTE BARE METAL STENT IN THE PROXIMAL CX, INFLATED TO 16 ATM FOR 30 SECONDS, WITH EXCELLENT RESULTS, NO RESIDUAL STENOSIS, AND TIMI III FLOW. THE PT HAD PERSISTENT CHEST PAIN AND RESPIRATORY DISCOMFORT. THEN, THE PHYSICIAN DEPLOYED A 3.0X20MM LIBERTE BARE METAL STENT IN THE PROXIMAL CX, INFLATED TO 16 ATM FOR 30 SECONDS, WITH EXCELLENT RESULTS, NO RESIDUAL STENOSIS, AND TIMI III FLOW. HOWEVER, THE OSTIAL DIAGONAL WAS NOTED TO BE JAILED FROM THE LAD INTERVENTION. THE INITIAL OSTIAL DIAGONAL HAD A 50% LESION AND AFTER THE INTERVENTION, IT HAD INCURRED A 90% DISCRETE LESION WHICH APPEARED TO BE CLINICALLY INSIGNIFICANT, AS THE PTS CHEST PAIN COMPLETELY RESOLVED. MEDICATIONS GIVEN: HEPARIN, NITROGLYCERIN, AND PLAVIX. PT WAS DISCHARGED 3 DAYS LATER. FOUR DAYS POST THE LIBERTE STENT PLACEMENT, THE PT PRESENTED VIA EMS WITH ACUTE CHEST PAIN AND DIAGNOSED WITH ACUTE INFERIOR AND POSTERIOR MYOCARDIAL INFARCTION AND WAS TAKEN TO THE CARDIAC CATH LAB. (PT WAS GIVEN NITROGLYCERIN EN ROUTE TO THE HOSP). PT HAD A RASH, WHICH SHE STATED WAS DUE TO A URINARY TRACT INFECTION. UPON ARRIVAL TO THE HOSPITAL, THE PT WAS GIVEN PLAVIX, ASPIRIN AND HEPARIN. PT BECAME UNRESPONSIVE, APNEIC, AND PULSELESS, ALTHOUGH RHYTHM WAS ON THE MONITOR. THE PT WAS INTUBATED AND CPR WAS BEGUN. PT WAS GIVEN EPINEPHRINE, GOOD COLOR CHANGE OCCURRED. THE PT BEGAN TO VOMIT AND SUCTION BEGAN WITH ADEQUATE RELIEF OF STOMACH CONTENTS. THE PT WAS GIVEN ATROPINE. A BEDSIDE ULTRASOUND CONFIRMED CARDIAC ACTIVITY WITHOUT A PULSE. CPR CONTINUED. THE PT WENT INTO VENTRICULAR FIBRILLATION WITHOUT A PULSE. THE PT WAS SHOCKED AND WENT BACK INTO A FAINT PULSE RHYTHM. EPINEPHRINE AND AMIODARONE WERE GIVEN. THE PT BECAME PULSELESS AND ATROPINE WAS GIVEN FOLLOWED BY EPINEPHRINE. AT THIS POINT CPR WAS HELD. THE PT HAD NO CARDIAC RHYTHM, NO PULSE, AND WAS NOT BREATHING. TIME OF DEATH WAS CALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC NA 11674587

    Patients

    Seq Age Sex Outcome Treatment
    1 Death