BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE SFA - IDE

    MDR report key: 2614566 · Received June 13, 2012

    Report

    Report Number
    9612164-2012-00984
    Event Type
    Malfunction
    Date Received
    June 13, 2012
    Date of Event
    October 18, 2010
    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
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION RESULTS - PATIENTS CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DIFFUSELY CALCIFIED LESION). 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 MID SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY ONE YEAR POST IMPLANT (B)(4) LAB, CONFIRMED A GRAD 1 STENT FRACTURE. IMAGE REVIEW: FOUR STILL IMAGES WERE PROVIDED FOR REVIEW. ONE OF THE STILL IMAGES SHOWS, THE SFA AS BEING MILDLY, BUT DIFFUSELY CALCIFIED. BASED ON REVIEW OF THE IMAGES THE STENT APPEARS TO BE COMPRESSED AT ONE POINT ON THE PROXIMAL END OF THE STENT. THIS APPEARS TO GIVE THE IMPRESSION THAT THERE HAS BEEN A STENT STRUT FRACTURE. BASED ON REVIEW OF THE IMAGES, IT APPEARS MOST LIKELY THAT THE COMPRESSIVE FORCES OF THE LESION IN THE VESSEL, IMPACTED ON THE PROFILE OF THE STENT. 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 00063 YR