BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPLETE SE PERIPHERAL STENT SYSTEM

    MDR report key: 2000450 · Received February 18, 2011

    Report

    Report Number
    2953200-2011-00433
    Event Type
    Death
    Date Received
    February 18, 2011
    Date of Event
    September 21, 2010
    Report Date
    January 20, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: (DEATH), (CAUSE OF DEATH UNKNOWN).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE 1 COMPLETE SE STENT WAS SUCCESSFULLY IMPLANTED TO THE DISTAL LEFT SFA. APPROXIMATELY 2 MONTHS POST INDEX PROCEDURE, MELANOMA OF THE LEFT LEG WAS REPORTED. PATIENT RECEIVED CHEMOTHERAPY AND RADIATION. APPROXIMATELY 7 MONTHS POST INDEX PROCEDURE THE PATIENT EXPIRED. THE INVESTIGATOR REPORTED NO RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. CAUSE OF DEATH IS UNKNOWN. COMPLETE SE SFA IS A PRE-MARKET DEVICE BUT IS SIMILAR TO COMPLETE SE BILIARY/ILIAC WHICH IS APPROVED IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE SE PERIPHERAL STENT SYSTEM NIO MEDTRONIC CARDIOVASCULAR SANTA ROSA NA V00221443

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death