BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2964049 · Received February 15, 2013

    Report

    Report Number
    2953200-2013-00269
    Event Type
    Death
    Date Received
    February 15, 2013
    Date of Event
    September 1, 2012
    Report Date
    January 23, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (DEVICE PLACED ON HOLD). RESULTS: INHERENT RISK OF PROCEDURE (DEATH, AMPUTATION), CAUSED BY ANOTHER DRUG/DEVICE (ENDOLEAK FROM THE TOP OF THE BIFURCATED STENT GRAFT). CONCLUSION: ANOTHER DEVICE CAUSED (ENDOLEAK FROM THE TOP OF THE BIFURCATED STENT GRAFT).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC DISSECTION APPROXIMATELY 11 MONTHS AGO. THE AORTIC NECK WAS SHORT AND ANGULATED. THE COMMON ILIAC ARTERIES WERE ECTATIC BILATERALLY. THE STENT GRAFTS WERE SUCCESSFULLY IMPLANTED AND THERE WERE NO COMPLICATIONS SINCE THE TIME OF IMPLANT. AT THE SIX MONTH FOLLOW-UP APPOINTMENT (DATE UNKNOWN) AN UNKNOWN ENDOLEAK WAS NOTED. THE PHYSICIAN SUSPECTED THIS WAS A TYPE II OR TYPE I ENDOLEAK. DUE TO THE PATIENT'S CONDITION THE DECISION WAS MADE TO EXPLANT THE STENT GRAFTS APPROXIMATELY TWO MONTHS AGO. AS AN OBSERVATION DURING THE EXPLANT PROCEDURE, IT WAS REPORTED THAT THERE WAS A PERSISTENT PROXIMAL TYPE I ENDOLEAK AROUND THE TOP OF THE STENT GRAFT. THROMBIN WAS INJECTED INTO THE ANEURYSM SAC. WHEN THE ILIAC LIMB WAS REMOVED THE LEFT ILIAC VEIN TORE RESULTING IN MASSIVE BLOOD LOSS. AFTER THE PROCEDURE THE PATIENT WAS SENT TO RECOVERY. ONE WEEK LATER THE PATIENT HAD BILATERAL LEG AMPUTATION AND EXPIRED TWO WEEKS LATER DUE TO MULTI-ORGAN FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66319 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01045177

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death