BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3790353 · Received May 5, 2014

    Report

    Report Number
    2134265-2014-02366
    Event Type
    Death
    Date Received
    May 5, 2014
    Date of Event
    March 23, 2014
    Report Date
    April 7, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT NAME: (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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

    SAME CASE AS MDR ID 2134265-2014-02367. (B)64) CLINICAL STUDY. IT WAS REPORTED THAT CARDIAC ARREST, VENTRICULAR FIBRILLATION, SEIZURES AND DEATH OCCURRED. IN (B)(6) 2011, THE PATIENT PRESENTED WITH SUBSTERNAL CHEST PAIN ASSOCIATED WITH SHORTNESS OF BREATH. THE PATIENT WAS DIAGNOSED WITH STABLE ANGINA. CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WAS PERFORMED ON THE FOLLOWING DAY. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 70% STENOSIS AND WAS 14 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.74 MM. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF TWO OVERLAPPING 3.50 X 12 MM TAXUS LIBERTÉ STENTS. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 9%. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2014, THE PATIENT PRESENTED EMERGENTLY IN THE HOSPITAL DUE TO CARDIAC ARREST. AT THE TIME OF EVENT, THE PATIENT WAS ON ASPIRIN AND CLOPIDOGREL. ALSO, THE STUDY DRUG PER PROTOCOL WAS NEVER TAKEN DURING THE STUDY. CARDIOPULMONARY RESUSCITATION (CPR) WAS STARTED EN ROUTE TO HOSPITAL AND WAS CARDIOVERTED SEVEN TIMES FOR VENTRICULAR FIBRILLATION. ADVANCED CARDIOVASCULAR LIFE SUPPORT (ACLS) MEASURES WERE INITIATED. PATIENT WAS INTUBATED AND PLACED ON ASSISTED MECHANICAL VENTILATION (AMV). THE PATIENT REMAINED COMATOSE AND DEVELOPED SEIZURES. TWO DAYS FROM ADMISSION, PATIENT'S FAMILY OPTED TO WITHDRAW LIFE SAVING MEASURES. THE PATIENT WAS THEN NOTED TO HAVE NO APICAL HEART RATE AND SPONTANEOUS RESPIRATIONS, OR BLOOD PRESSURE AND PUPILS WERE DILATED AND FIXED BILATERALLY. PATIENT WAS PRONOUNCED DEAD AT 17:28 HOURS ON THE SAME DAY. THE PRIMARY CAUSE OF DEATH WAS CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266623 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893712350 13427057

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| H| R