BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 4213530 · Received October 30, 2014

    Report

    Report Number
    2134265-2014-06555
    Event Type
    Death
    Date Received
    October 30, 2014
    Date of Event
    July 5, 2014
    Report Date
    October 6, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT DEATH OCCURRED. IN (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA, NON ST SEGMENT ELEVATION MYOCARDIAL INFARCTION AND CARDIAC CATHETERIZATION WAS RECOMMENDED. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WERE PERFORMED. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE DISTAL LEFT CIRCUMFLEX (LCX) WITH 80% STENOSIS AND WAS 7 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.6 MM. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 2.50 X 12 MM TAXUS® LIBERTÉ® STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2014 AT UNSPECIFIED TIME, THE PATIENT DIED DUE TO AN UNKNOWN CAUSE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT IN (B)(6) 2014 AT 6.51 A.M, THE PATIENT DIED AT HOME AND AS PER DEATH CERTIFICATE, THE CAUSE OF DEATH WAS MYOCARDIAL INFARCTION. NO AUTOPSY WAS PERFORMED. IN ADDITION, AT THE TIME OF THE EVENT, IT WAS UNKNOWN WHETHER THE PATIENT WAS TAKING ASPIRIN OR 'OTHER' ANTIPLATELET MEDICATION AND THE STUDY DRUG WAS NEVER TAKEN DURING THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695911 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893612250 13116903

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death