BEUDAMED
    FDA Adverse Event Death Summary report: N

    S.M.A.R.T. NITINOL STENT SYSTEM

    MDR report key: 5106303 · Received September 26, 2015

    Report

    Report Number
    9616099-2015-00459
    Event Type
    Death
    Date Received
    September 26, 2015
    Date of Event
    June 12, 2015
    Report Date
    September 7, 2015
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K042969
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS REPORTED FROM THE (B)(6) STUDY, ON (B)(6) 2013 THE SMART STENT WAS PLACED IN THE TARGET LESION WITHOUT ANY ISSUE. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY. THE LESION WAS MODERATELY CALCIFIED AND MILDLY TORTUOUS. THE RATE OF STENOSIS WAS 100%. ON (B)(6) 2015, THE PATIENT WAS HOSPITALIZED FOR HEART FAILURE REVIVAL AND RECEIVED MEDICATION. ON (B)(6) 2015, THE PATIENT EXPIRED. ADDITIONAL INFORMATION RECEIVED THAT THERE WAS NO EXACT KNOWN CAUSE OF DEATH. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. WITHOUT FURTHER TESTING, IT IS NOT POSSIBLE TO DETERMINE THE SOURCE OF THE EVENT. CONGESTIVE HEART FAILURE IS A CARDIAC CONDITION THAT OCCURS WHEN A PROBLEM WITH THE STRUCTURE OR FUNCTION OF THE HEART IMPAIRS ITS ABILITY TO SUPPLY SUFFICIENT BLOOD FLOW TO MEET THE BODY'S NEEDS. RIGHT-SIDED HEART FAILURE CORRESPONDS WITH FAILURE OF THE RIGHT VENTRICLE AND CAUSES CONGESTION OF SYSTEMIC CAPILLARIES GENERATING EXCESS FLUID ACCUMULATION IN THE BODY (PERIPHERAL EDEMA). THE MAIN CAUSES OF HEART FAILURE INCLUDE ISCHEMIC HEART DISEASE, HYPERTENSION, DIABETES, SMOKING AND OBESITY. THERE IS NO INDICATION THAT THE EVENT WAS RELATED TO A DESIGN OR MANUFACTURING ISSUE, THEREFORE NO CORRECTIVE ACTION IS NEEDED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED FROM THE (B)(4) SMART PMS FOR SFA STUDY, ON (B)(6) 2013 THE SMART STENT WAS PLACED IN THE TARGET LESION WITHOUT ANY ISSUE. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY. THE LESION WAS MODERATELY CALCIFIED AND MILDLY TORTUOUS. THE RATE OF STENOSIS WAS 100%. ON (B)(6) 2015, THE PATIENT WAS HOSPITALIZED FOR HEART FAILURE REVIVAL AND RECEIVED MEDICATION. ON (B)(6) 2015, THE PATIENT EXPIRED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637849 S.M.A.R.T. NITINOL STENT SYSTEM SELF EXPANDING STENTS (FGE) FGE CORDIS CORPORATION NA 15851698

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| R