BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPLETE SE SFA

    MDR report key: 3476134 · Received November 19, 2013

    Report

    Report Number
    9612164-2013-01094
    Event Type
    Death
    Date Received
    November 19, 2013
    Date of Event
    October 26, 2013
    Report Date
    November 15, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIP
    PMA / PMN Number
    P110040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE ¿ (DEATH). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (DEATH). (B)(4).

    Description of Event or Problem · 1

    TWO COMPLETE SE PERIPHERAL STENTS WERE IMPLANTED IN A LESION OF A PATIENT LOCATED IN THE SFA TO POPLITEAL OF THE LEFT LEG. IT IS REPORTED THAT APPROXIMATELY 5 MONTHS POST INDEX PROCEDURE THE PATIENT EXPIRED. INVESTIGATOR INDICATED THE EVENT WAS NOT RELATED TO THE DEVICE OR PROCEDURE..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599021 COMPLETE SE SFA STENT, SUPERFICIAL FEMORAL ARTERY NIP MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Death| R CLOPIDOGREL AND ASPIRIN.