BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMART 120 150, SFA - 7X150MM

    MDR report key: 7744943 · Received August 2, 2018

    Report

    Report Number
    9616099-2018-02281
    Event Type
    Death
    Date Received
    August 2, 2018
    Date of Event
    May 28, 2018
    Report Date
    August 2, 2018
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K042969
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED BY THE PMS STUDY, TWO SMART STENTS (SFA - 7X150MM, SFA - 7X150MM AND A SMART CONTROL (ILIAC 6X40ML) STENT WERE IMPLANTED INTO THE PROXIMAL PORTION OF THE RIGHT FEMORAL ARTERY, WITHOUT ANY ISSUE. APPROXIMATELY FOUR YEARS AND ELEVEN MONTHS AFTER THE INDEX PROCEDURE, IT WAS REPORTED THAT THE PATIENT EXPIRED AND DETAILS PERTAINING TO THE DEATH WERE UNKNOWN. RELEVANCY OF THE DEATH WITH THE PRODUCT ARE UNKNOWN AND TREATMENT IS ALSO UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED AND THE DETAILS ABOUT THE DEATH AND DEATH CERTIFICATE ARE UNAVAILABLE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) ASSOCIATED WITH LOT 15851699 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. BASED ON THE LIMITED INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT ¿DEATH¿ COULD NOT BE CONFIRMED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. GIVEN THE LIMITED INFORMATION AVAILABLE FOR REVIEW, A RELATION BETWEEN THE DEVICE AND THE EVENT COULD NOT BE DETERMINED. DEATH DOES NOT REPRESENT A DEVICE MALFUNCTION AS THE DEATH OCCURRED FIVE YEARS AFTER THE DEVICES WERE IMPLANTED. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO PREVENTATIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE REPORTING REFERENCE NUMBER FOR THIS EVENT IS 9616099-2018-02281. THE REPORT REFERENCE NUMBER FOR THE OTHER TWO COMPLAINTS ARE COMPLAINT ARE 9616099-2018-02282 AND 9616099-2018-02283.

    Description of Event or Problem · 1

    AS REPORTED BY THE PMS STUDY, TWO SMART STENTS AND A SMART CONTROL STENT WERE IMPLANTED INTO THE PROXIMAL PORTION OF THE RIGHT FEMORAL ARTERY, WITHOUT ANY ISSUE. APPROXIMATELY FOUR YEARS AND ELEVEN MONTHS AFTER THE INDEX PROCEDURE IT WAS REPORTED THAT THE PATIENT EXPIRED AND DETAILS PERTAINING TO THE DEATH WERE UNKNOWN. RELEVANCY OF THE DEATH WITH THE PRODUCT ARE UNKNOWN AND TREATMENT IS ALSO UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583424 SMART 120 150, SFA - 7X150MM CATHETER, BILIARY, DIAGNOSTIC FGE CORDIS CORPORATION 15851699

    Patients

    Seq Age Sex Outcome Treatment
    1 Death