BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT IIS BIFURCATED STENT GRAFT

    MDR report key: 6330802 · Received February 14, 2017

    Report

    Report Number
    2953200-2017-00205
    Event Type
    Death
    Date Received
    February 14, 2017
    Date of Event
    January 26, 2017
    Report Date
    January 26, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    UDI-DI
    00643169439955
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: ETEW1010C82E, SN (B)(4), EXPIRATION DATE: 01/09/2019, (B)(4), ETEW1010C82E, SN (B)(4), EXPIRATION DATE: 01/05/2019, (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 8.0 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS NOTED THAT THE PATIENT¿S ACCESS VESSELS WERE SMALL IN DIAMETER. THE ILIAC ARTERIES WERE MODERATELY CALCIFIED. PRIOR TO THE ENDURANT STENT GRAFT BEING INSERTED INTO THE PATIENT THE FOLLOWING EVENT OCCURRED. ANOTHER MANUFACTURER¿S 5 FR SHEATH WAS INSERTED INTO THE RIGHT COMMON FEMORAL ARTERY. DURING THE INSERTION OF THE 5 FR SHEATH THE ILIAC ARTERY WAS PERFORATED AT THE COMMON FEMORAL ARTERY DUE. AFTER THE PERFORATION WAS NOTED ON THE RIGHT SIDE, THE 5 FR SHEATH WAS REMOVED FROM THE PATIENT AND A 20 FR SENTRANT SHEATH WAS INSERTED IN THE PATIENT TO ENABLE HEMOSTASIS. ON THE LEFT SIDE, ANOTHER MANUFACTURER¿S 12 FR WAS INSERTED, IT WAS NOTED THAT THE VALVE OF THE 12 FR SHEATH TORE/BROKE, CAUSING BLOOD TO EXIT THE SHEATH. THE 12 FR SHEATH WAS REMOVED AND A 14 FR SHEATH WAS INSERTED UP TO THE EXTERNAL ILIAC ARTERY. THE ENDURANT STENT GRAFTS WERE ADVANCED, SUCCESSFULLY IMPLANTED, AND SEAL WAS CONFIRMED. AFTER THE STENT GRAFTS WERE IMPLANTED THE PHYSICIAN ELECTED TO MODEL THE ENDURANT STENT GRAFTS WITH A RELIANT BALLOON AT THE DISTAL PORTION OF THE RIGHT ILIAC STENT GRAFT. DURING THE BALLOON INFLATION THE RIGHT EXTERNAL ILIAC ARTERY WAS PERFORATED DISTAL TO THE ENDURANT STENT GRAFT 16X10X156, DUE TO BALLOONING. AN ENDURANT STENT GRAFT 10X10X82 WAS IMPLANTED IN THE RIGHT EXTERNAL ILIAC ARTERY AND THE PERFORATION WAS COVERED. AN ANGIOGRAM DEMONSTRATED THAT DISTAL TO THE ENDURANT 16X10X124 THE LEFT EXTERNAL ILIAC ARTERY HAD A DISSECTION AND ELECTED TO IMPLANT AN ENDURANT 10X10X82 LIMB AND ANOTHER MANUFACTURER¿S COVERED STENT UP TO THE JUNCTION OF THE INTERNAL/EXTERNAL BIFURCATION. THE ANGIOGRAM WAS PERFORMED ON BOTH ILIAC ARTERIES AND SEAL WAS CONFERRED AND NO ENDOLEAK PRESENT. AFTER THE PATIENT WAS CLOSED, THE PATIENT WAS BEING TRANSFERRED FROM THE OPERATION ROOM BED TO THE ICU BED, AND THE PATIENT¿S BLOOD PRESSURE DROPPED. EXPLORATORY LAPAROTOMY WAS PERFORMED WHICH REVEALED A TOTAL SEPARATION OF THE LEFT COMMON ILIAC ARTERY FROM THE INTERNAL/EXTERNAL BIFURCATION. THE PATIENT HAD LOST TOO MUCH BLOOD AND EXPIRED. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS RELATED TO THE PATIENT¿S ANATOMY; SPECIFICALLY, THE CALCIFIED ILIAC'S AND ACCESS VESSELS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111390 ENDURANT IIS BIFURCATED STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ESBF3614C103E 00643169439955

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| R