BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2764961 · Received September 28, 2012

    Report

    Report Number
    2953200-2012-01875
    Event Type
    Injury
    Date Received
    September 28, 2012
    Report Date
    September 3, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION CODES, RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION, CONVERSION TO SURGICAL REPAIR); OTHER (CAUSE IS UNKNOWN) EVALUATION CODES, CONCLUSION: OTHER (CAUSE IS UNKNOWN).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY THREE YEARS AGO. ANGLE BETWEEN PROXIMAL AAA NECK AND MAIN AXIS OF AAA IS 16, AORTIC NECK BELOW THE RENALS IS 23 MM, DISTAL DIAMETER IS 24 MM, ITS LENGTH IS 21 MM AND THE ANEURYSM IS FUSIFORM IN SHAPE WITH A DIAMETER OF 50 MM. THE INVESTIGATOR ASSESSED THERE WAS UNINTENTIONAL MOVEMENT OF THE STENT GRAFT. IT WAS REPORTED THAT AN EVENT OF STENT GRAFT THROMBOSIS OCCURRED SIX MONTHS POST INDEX PROCEDURE. THE PATIENT HAD A THROMBECTOMY WITH POOR INFLOW. RIGHT ILIO-FEMORAL BYPASS, LEFT FEM-FEM CROSSOVER, ENDARTECTOMY LEFT CFA, PFK, AND SFA. THE EVENT RESOLVED THREE DAYS LATER. THE INVESTIGATORS ASSESSMENT STATES THAT THE EVENT IS RELATED TO THE STUDY DEVICE AND STUDY PROCEDURE. THERE WAS ALSO A RIGHT ILIAC LIMB OCCLUSION WITH AN INTERVENTION AT THE SAME TIME AS THE PREVIOUS PROCEDURE. THERE WAS TIGHT STENOSIS OF THE PROXIMAL RIGHT LIMB OF THE GRAFT (BIFUR.). TWO ATRIUM STENTS WERE PLACED TO RESOLVE THE EVENT. IT WAS REPORTED THAT EIGHT MONTHS POST INDEX PROCEDURE THAT THE PATIENT HAD STENT GRAFT STENOSIS REQUIRING A SECONDARY INTERVENTION. AN OPEN PROCEDURE WAS PERFORMED. A RIGHT AXILLOFEMORAL GRAFT AND A FEMORAL-FEMORAL CROSS OVER GRAFT WAS PERFORMED WITH THE EVENT RESOLVING AND THE PATIENT RECOVERING. THE INVESTIGATOR ASSESSMENT STATES THAT THE EVENT OF STENT GRAFT STENOSIS IS RELATED TO THE STUDY DEVICE; HOWEVER IS NOT RELATED TO THE STUDY PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PAT IENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00281478

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention