Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Patient medical history includes but is not limited to: liver cancer currently being treated with tace, aaa, alcohol dependence, hypertension, joint pain, left leg pain, liver lesion, left lobe, liver mass, pad.Concomitant medical devices: patient medications include but are not limited to: acetaminophen.The instructions for use (ifu) for the gore® viabahn® endoprosthesis states the following: hazards and adverse events, procedure related: as with all procedures that utilize techniques for introducing a catheter into a vessel, complications may be expected.These complications include, but are not limited to: death.
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On (b)(6) 2021, this patient underwent endovascular treatment of a symptomatic abdominal aortic aneurysm with short distance claudication of both lower extremities and bilateral iliac artery occlusions; with complete occlusion of the right external iliac artery (rcia) and left common iliac artery (lcia).Post dissection of the bilateral cia¿s a gore® viabahn® vbx balloon expandable endoprosthesis (vbx stent graft) was advanced and deployed within the rcia and extended with a gore® viabahn® endoprosthesis with heparin bioactive surface down to the reia and inflated to 12mmhg.A 16 fr sheath was then advanced through the right iliac viabahn® system and a gore® excluder® trunk ipsilateral leg component featuring c3® delivery system was advanced and deployed just distal to the renal arteries.A second trunk ipsilateral leg component of the same size was then advanced and deployed to overlap the first one.Angioplasty of the entire system was performed all the way down to the common and external iliac¿s.Completion angiography demonstrated no endoleak and a widely patent graft system and a femoral to femoral artery bypass was performed.An angiograph was performed and showed two areas of sluggish flow within the bypass system and a gore® viabahn® endoprosthesis was implanted and dilated with a 8mm diameter balloon.Completion imaging was performed and demonstrated inline and brisk, pulsatile flow.The patient tolerated the procedure and was transferred to recovery in fair condition.On (b)(6) 2021, the patient expired from a likely combination of cardiogenic shock and hypovolemic shock.The patient suffered hepatocellular carcinoma and presume to develop hepatic coagulopathy on top of arteriosclerotic cardiovascular disease.
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