BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE SFA - IDE

    MDR report key: 2614555 · Received June 13, 2012

    Report

    Report Number
    9612164-2012-00983
    Event Type
    Malfunction
    Date Received
    June 13, 2012
    Date of Event
    March 8, 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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (CALCIFICATION); DEVICE NOT RECEIVED FOR EVALUATION; CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (CALCIFICATION).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, THE PATIENT HAD ONE COMPLETE SELF EXPANDING (SE) PERIPHERAL STENT IMPLANTED TO THE RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 1 YEAR POST INDEX PROCEDURE, THE CORE LAB CONFIRMED A GRADE 1 STENT FRACTURE. IMAGE REVIEW: THREE (3) STILL IMAGES OF THE STENT AT THE 12 MONTH FOLLOW-UP WERE PROVIDED FOR REVIEW. REVIEW OF THESE IMAGES BY THE CORE LAB IDENTIFIED A GRADE 1 STENT FRACTURE. THE STILL IMAGES SHOW WHAT APPEARS TO BE COMPRESSION OF THE STENT IN CONFORMANCE WITH THE VESSEL MORPHOLOGY. THERE APPEARS TO BE A DEGREE OF CALCIFICATION WITHIN THE VESSEL. BASED ON REVIEW OF THE 12 MONTH IMAGES IT APPEARS MOST LIKELY THAT THE COMPRESSIVE FORCES WITHIN 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 00075 YR