BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3024340 · Received March 27, 2013

    Report

    Report Number
    2953200-2013-00542
    Event Type
    Death
    Date Received
    March 27, 2013
    Date of Event
    September 20, 2012
    Report Date
    February 28, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: DEATH, VESSEL OCCLUSION, EMBOLI. EMBOLI. RENAL STENT. CONCLUSION: EMBOLI. RENAL STENT.

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A LARGE ABDOMINAL AORTIC ANEURYSM APPROXIMATELY SIX MONTHS AGO. THE STENT GRAFTS WERE SUCCESSFULLY IMPLANTED WITH THE BIFURCATED STENT GRAFT BEING PLACED CLOSE TO ONE OF THE RENAL ARTERIES. A RENAL STENT WAS PLACED PROACTIVELY ALTHOUGH BOTH RENALS FILLED DURING ANGIO. BASED ON THE PATHOLOGISTS REPORT, THERE MAY HAVE BEEN AN ISSUE OF PARTICLES BEING INTRODUCED INTO THE GLOMERULAR CAPILLARIES AS A RESULT OF STENT PLACEMENT. IT WAS REPORTED THAT THERE WERE TECHNICAL DIFFICULTIES WITH THE PLACEMENT OF THE STENT GRAFTS AND THERE WAS CONCERN THAT THERE WAS SOME IMPINGEMENT OF THE RENAL ARTERIES. A RENAL STENT WAS PLACED ON THE RIGHT SIDE TO ENSURE THAT THE RENAL ARTERY WAS PATENT; HOWEVER, IT WAS NOT POSSIBLE TO PLACE A STENT ON THE LEFT SIDE AND THE PATIENT WAS WATCHED VERY CLOSELY POST-OPERATIVELY AND THERE WAS CONCERN ABOUT RENAL FUNCTION. THE PATIENT WAS OBSERVED IN THE HOSPITAL FOR TWO DAYS. ON THE FIRST POST-OPERATIVE DAY, THE CREATININE LEVEL WENT UP FROM THE BASELINE OF 0.8 TO 1.5. AND IT CAME DOWN SLIGHTLY THE NEXT DAY. TWO DAYS POST-OPERATIVELY THE CREATININE LEVEL WAS BELOW 1.0. THE PATIENT WAS DISCHARGED. THE PATIENT WAS RE-ADMITTED ON AN UNKNOWN DATE AND WAS DISCHARGED. IT WAS REPORTED THAT THE PATIENT WAS FOUND TO HAVE ACUTE RENAL FAILURE WITH CREATININE OF 9.34, HYPONATREMIA AND HYPERKALEMIA. THE PATIENT WAS IMMEDIATELY STARTED ON DIALYSIS. A LEFT RENAL BIOPSY DONE AND THE RESULT WAS CONSISTENT WITH POSSIBLE EMBOLI TO THE LEFT KIDNEY. THERE WAS NO BIOPSY DONE ON THE RIGHT KIDNEY DUE TO THE RECENT PLACEMENT OF THE RIGHT ARTERY STENT. IT WAS REPORTED THAT THE PATIENT COMMITTED SUICIDE A SHORT TIME LATER, DATE UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125294 ENDURANT II ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01096015

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention