BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPLETE SE SFA - IDE

    MDR report key: 2614872 · Received June 13, 2012

    Report

    Report Number
    9612164-2012-00985
    Event Type
    Death
    Date Received
    June 13, 2012
    Date of Event
    April 30, 2010
    Report Date
    May 14, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: (ROOT CAUSE UNDETERMINED - MATERIAL DISTORTION APPEARS TO HAVE BEEN MOST LIKELY PROCEDURAL RELATED BUT THIS CANNOT BE CONFIRMED), INHERENT RISK OF PROCEDURE (DEATH), (DEVICE NOT RECEIVED FOR EVALUATION).

    Description of Event or Problem · 1

    TWO COMPLETE SE STENTS WERE IMPLANTED TO THE RIGHT SFA DURING INDEX PROCEDURE, ONE TO THE DISTAL VESSEL AND ONE TO THE PROXIMAL VESSEL. NO DEVICE MALFUNCTION OCCURRED AT TIME OF IMPLANT. APPROXIMATELY 1 YEAR POST INDEX PROCEDURE, A STENT FRACTURE (GRAD 2) WAS REPORTED BY THE CORE LAB. APPROXIMATELY TWO YEARS POST INDEX PROCEDURE, PATIENT DEATH OCCURRED RELATED TO MI AND CARDIAC DECOMPENSATION. INVESTIGATOR REPORTS NO RELATIONSHIP TO STUDY DEVICE. IMAGE REVIEW: THE STILL IMAGES SHOW WHAT APPEARS TO BE COMPRESSION OF THE STENT STRUTS ON THE PROXIMAL END OF THE STENT. 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. (REF MFR REPORT #S 9612164-2012-00985 AND 9612164-2012-0986).

    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 Death