BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II AUI

    MDR report key: 3820783 · Received May 20, 2014

    Report

    Report Number
    2953200-2014-01033
    Event Type
    Death
    Date Received
    May 20, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: TREATMENT OF A PATIENT WITH A JUXTARENAL ANEURYSM.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED; HOWEVER, IT WAS NOTED THAT THE PATIENT PRESENTS A JUXTARENAL ABDOMINAL AORTIC ANEURYSM MEASURING 5.7CM. THE AAA EXTENDS TO THE RENAL ARTERIES AND EXTENDS DOWN TO APPROX. 3-4 CM ABOVE THE AORTIC BIFURCATION. HEAVILY CALCIFIED AORTIC BIFURCATION MEASURING 13MM. THE RIGHT AND LEFT ILIAC ARTERIES ARE HEAVILY CALCIFIED MEASURING 4-5MM. DURING THE INDEX PROCEDURE THE PHYSICIAN PLANNED TO DO A 3 VESSEL SNORKEL COMING FROM THE SUBCLAVIAN. PLACING AN AUI DEVICE TO THE LEVEL OF THE CELIAC ARTERY AND EXTEND WITH A 16X13X82 TO THE AORTIC BIFURCATION. THE PHYSICIAN PLACED ANOTHER MANUFACTURER¿S STENT IN THE BIFURCATION. THE PHYSICIAN PERFORMED A CUT DOWN ON THE SUBCLAVIAN ARTERY AND PLACED A 10MM CONDUIT ON FOR ACCESS FROM ABOVE, THEN PLACED ANOTHER MANUFACTURER¿S 24 FRENCH SHEATH IN THE CONDUIT. THROUGH THAT SHEATH 3 OTHER MANUFACTURER¿S SHEATHS WERE PLACED INTO THE SMA, RIGHT RENAL, AND LEFT RENAL ARTERY. THE LEFT COMMON ILIAC WAS ACCESSED WITH A 6 FRENCH SHEATH. THE RIGHT ILIAC WAS PRE-CLOSED FOR A PERCUTANEOUS APPROACH FOR THE ENDURANT DEVICE. ANOTHER MANUFACTURER¿S STENT WAS PLACED INTO THE RIGHT AND LEFT RENAL SHEATH. ANOTHER MANUFACTURER¿S STENT WAS PLACED IN THE SMA SHEATH. THE ENDURANT WAS PLACED UP THE RIGHT SIDE. AT THIS TIME THE PHYSICIAN EXPERIENCED DIFFICULTIES WITH THE 24 FRENCH SHEATH LEAKING AND BLOOD LOSS WAS BECOMING AN ISSUE. THE PHYSICIAN CONFIRMED WHERE THE RENAL STENTS NEEDED TO BE AND DEPLOYED THEM. AT THE TIME OF DEPLOYMENT THE RIGHT STENT DID NOT DEPLOY IN THE ORIGIN OF THE RENAL AND THE LEFT STENT WAS NOT LONG ENOUGH. THE PHYSICIAN EXTENDED BOTH SIDES WITH ANOTHER MANUFACTURER¿S STENT. SUBSEQUENTLY THE ENDURANT WAS DEPLOYED AS WELL AS THE OTHER MANUFACTURER¿S SMA STENT. THE ENDURANT DELIVERY SYSTEM WAS TAKEN OUT AND REPLACED WITH A 16 FRENCH SENTRANT SHEATH. A RELIANT BALLOON WAS INTRODUCED AND ALL THREE BALLOONS AND THE RELIANT BALLOON WERE INFLATED. THE RELIANT BALLOON WAS TAKEN OUT. THE RIGHT AND LEFT RENAL BALLOON WERE TAKEN OUT AS WELL. AS THE PHYSICIAN WAS TRYING TO TAKE THE SMA BALLOON OUT IT GOT CAUGHT ON THE SUPRA RENAL STENT AND THE ENDURANT DEVICE GOT DISLODGED AND MOVED UP. AFTER MANIPULATION THE BALLOON WAS REMOVED. THE PHYSICIAN PERFORMED A COMPLETION ANGIOGRAM TO CONFIRM PATENCY OF THE VISCERAL VESSELS AND THE RENAL ARTERIES. THE PROXIMAL PART LOOKED GREAT. DUE TO THE BLOOD LOSS THE DECISION WAS MADE TO TAKE ALL THREE SHEATHS OUT OF THE CONDUIT. THE PHYSICIAN TOOK THE RIGHT AND LEFT RENAL SHEATH OUT AND WHEN THE PHYSICIAN WENT TO PULL THE SMA SHEATH, FELT RESISTANCE AND KEPT PULLING THINKING IT WAS THE BALLOON ON THE DRY SEAL. ON THE FINAL FLUORO THE ENDURANT GRAFT WAS NOT ON THE SCREEN. THE DEVICE WAS IN THE DESCENDING AORTA AT THE LEVEL OF THE SUBCLAVIAN. THE SMA STENT WAS ALSO FLOATING IN THE AORTA. THE PHYSICIAN TRIED TO PULL THE GRAFT DOWN BUT THE SUPRA RENAL STRUT WAS IN THE SUBCLAVIAN. UPON MULTIPLE ANGIOGRAMS AND CONSULTATION WITH A CT SURGEON, THE DECISION WAS MADE TO LEAVE THE DEVICE IN PLACE. THE PHYSICIAN DECIDED TO PLACE ANOTHER MANUFACTURER¿S STENT TO PROTECT THE SUBCLAVIAN ARTERY AND THE PATIENT¿S LIMA GRAFT. THE PATIENT WAS HEMODYNAMICALLY STABLE AT THIS POINT SO THE DECISION WAS MADE TO PLACE A SECOND AUI DEVICE TO THE LEVEL OF THE SMA SINCE THAT STENT WAS NOT IN PLACE ANYMORE. THE SECOND ENDURANT WAS PLACED AND EXTENDED WITH A 16X13X82 TO THE LEVEL OF THE AORTIC BIFURCATION. THEN PLACED 2 KISSING STENTS INTO THE RIGHT AND LEFT ILIAC. THE COMPLETION ANGIOGRAM SHOWED GOOD FILLING OF ALL THE VISCERAL VESSELS AS WELL AS THE DISTAL AORTA. THE DAY AFTER THE PROCEDURE THE PATIENT'S RIGHT LEG BECAME ISCHEMIC AND THE PHYSICIAN SENT THE PATIENT BACK TO THE OR FOR A SECONDARY PROCEDURE WHERE A RIGHT EXTERNAL ILIAC DISSECTION WAS FOUND. THE PHYSICIAN DE-CLOTTED THE RIGHT LEG AND USED CONTRAST. THE CAUSE OF THE DISSECTION IS UNKNOWN; HOWEVER, IT WAS NOTED THAT THE PATIENT'S VESSELS WERE VERY CALCIFIED AND DISEASED. THE PATIENT DETERIORATED AFTER THE SECONDARY INTERVENTION AND DID NOT RECOVER. THE PATIENT EXPIRED FOUR DAYS LATER DUE TO RENAL FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300419 ENDURANT II AUI SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04080443

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Death| R