BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2921045 · Received January 17, 2013

    Report

    Report Number
    2953200-2013-00104
    Event Type
    Death
    Date Received
    January 17, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (DEATH); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (SEVERELY CALCIFIED ILIAC ARTERIES). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (SEVERELY CALCIFIED ILIAC ARTERIES).

    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 ONE MONTH AGO. THE PATIENT HAD SEVERE CALCIFICATION THROUGHOUT AORTA TO THE ILIAC ARTERIES. AN ENDURANT BIFURCATED STENT GRAFT (B)(4), AND THREE ILIAC LIMB STENT GRAFTS (B)(4), (B)(4) AND (B)(4) WERE IMPLANTED IN THE PATIENT. AN 18FR SHEATH WAS ATTEMPTED BUT IT WOULD NOT GO UP THE CALCIFIED ILIAC ARTERIES; THEREFORE, THE PROCEDURE WAS DONE USING THE PERCUTANEOUS APPROACH. THE ENDURANT BIFURCATED STENT GRAFT WAS ATTEMPTED TO BE INSERTED; HOWEVER, IT WAS NOT POSSIBLE TO GET THE DELIVERY SYSTEM TO ADVANCE TO THE LOCATION OF THE ANEURYSM. A 14FR DILATOR WAS INSERTED AND IT WAS ABLE TO SUCCESSFULLY ADVANCE. THEN A 16FR DILATOR WAS ATTEMPTED BUT COULD NOT BE ADVANCE. AN 18FR DILATOR WAS ALSO ATTEMPTED BUT IT COULD NOT ADVANCE. THE COMMON ILIAC ARTERY WAS BALLOONED THEN BIFURCATED STENT GRAFT WAS ABLE TO BE INSERTED AND PARTIALLY DEPLOYED IN ORDER TO CANNULATE THE CONTRALATERAL GATE; HOWEVER IT WAS NOT POSSIBLE TO CANNULATE THE GATE. THE BIFURCATED STENT GRAFT WAS THEN FULLY DEPLOYED FOLLOWED BY AN ILIAC EXTENSION ON THE IPSILATERAL SIDE. THE PHYSICIAN ATTEMPTED A SNARE SEVERAL TIMES AND BALLOONED THE LEFT SIDE AND FINALLY WAS ABLE TO GET THE SNARE A WIRE ON THE CONTRALATERAL SIDE AND WAS ABLE TO IMPLANT THE CONTRALATERAL STENT GRAFT AND EXTENSION. THE FINAL ANGIOGRAM SHOWED THAT THERE WAS A TYPE I AND TYPE II ENDOLEAK. THE PHYSICIAN DECIDED TO BALLOON THE AORTIC NECK AND THE ENTIRE STENT GRAFT. THE TYPE I ENDOLEAK RESOLVED AND THE TYPE II ENDOLEAK REMAINED. IT WAS NOTED THAT THERE WAS A HEMATOMA AT THE RIGHT GROIN. DURING THE PROCEDURE 2 UNITS OF BLOOD WERE GIVEN. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE AND WAS SENT TO RECOVERY BUT THE PATIENT EXPIRED THE NEXT MORNING. NO AUTOPSY WILL BE PERFORMED. THE PHYSICIAN STATED THAT THE CAUSE OF DEATH IS RELATED TO CARDIAC ISSUES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27182 ENDURANT II ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01731603

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Death