BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE SFA - IDE

    MDR report key: 2614476 · Received June 13, 2012

    Report

    Report Number
    9612164-2012-00982
    Event Type
    Malfunction
    Date Received
    June 13, 2012
    Date of Event
    May 24, 2011
    Report Date
    May 14, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DIFFUSELY CALCIFIED LESION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (DIFFUSELY CALCIFIED LESION).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, THE PATIENT HAD ONE COMPLETE SELF EXPANDING (SE) PERIPHERAL STENT IMPLANTED TO THE LEFT PROXIMAL POPLITEAL ARTERY (PPA). APPROXIMATELY 1 YEAR POST INDEX PROCEDURE, THE CORE LAB REPORT A GRAD 1 STENT FRACTURE. IMAGE REVIEW: ONE OF THE STILL IMAGES SHOWS THAT THE SFA TO POPLITEAL ARTERY AS BEING MILDLY, BUT DIFFUSELY CALCIFIED. THE STENT APPEARS TO BE COMPRESSED ON ITS PROXIMAL END. COMPLETE SE SFA IS UNDER INVESTIGATION PURSUANT TO AN IDE. THE DEVICE IS CURRENTLY APPROVED IN THE U.S. WITH AN ILIAC AND BILIARY INDICATION.

    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 00058 YR