BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPLETE SE SFA - IDE

    MDR report key: 2500800 · Received March 23, 2012

    Report

    Report Number
    9612164-2012-00485
    Event Type
    Death
    Date Received
    March 23, 2012
    Date of Event
    January 5, 2011
    Report Date
    July 18, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, THE PATIENT HAD ONE COMPLETE SELF EXPANDING (SE) PERIPHERAL STENT IMPLANTED TO THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY. APPROXIMATELY 21 MONTHS POST INDEX PROCEDURE, PATIENT DEATH OCCURRED. CAUSE OF DEATH IS UNKNOWN. COMPLETE SE SFA IS NOT APPROVED FOR USE IN THE US, BUT IT IS SIMILAR TO COMPLETE SE ILIAC/BILIARY WHICH ARE APPROVED FOR USE.

    Description of Event or Problem · 1

    CAUSE OF DEATH PROVIDED AS: RESULT OF COMPLICATIONS FROM AN APARTMENT FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE SE SFA - IDE STENT, ILIAC NIO MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death