Lot/serial:(b)(4)= udi: (b)(4).The concomitant medical products are four gore® excluder® aaa endoprosthesis (rmt261418/12505275, pxc121200/13287588, pxc141200 /13426725, pxc141400/13580484) and one gore® viabahn® endoprosthesis (vbc101002/12878005).The therapy date was(b)(6) 2015.The review of the manufacturing records verified that this lot met all pre-release specifications.
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It was reported to gore that on (b)(6) 2015 the patient was implanted with two gore viabahn endoprosthesis (vbc101002/12878005, vbc131002/13685144) in the right femoral artery and four gore excluder aaa endoprosthesis, for treatment of a massive aneurysm from the abdominal artery to the right femoral artery.Access for viabahn devices was performed from the popliteal artery.It was stated that the right femoral artery aneurysm started to rupture before the operation and the conditions of blood vessel were poor.The post-deployment angiography reportedly showed a small type i endoleak from the distal portion of the gore viabahn endoprosthesis.After the operation, it was stated that the patient experienced post-operative oligochromemia and a 1g decrease of hemachrome per day, but improved after clinical treatment by transfusion and drug administration.On an unknown date after surgery, a bedside ultrasound revealed peritoneal effusion.A mixed enclosed mass was revealed in the right upper abdomen, it is not clear of the source of the mass and needs further inspection to confirm.The abdominal aneurysm with thrombus was detected after the stent graft being implanted.The right femoral artery implanted with stent graft was detected with mixed enclosed mass.Both limb arteries were detected with atherosclerosis.On (b)(6) 2015, the patient complained of abdominal pain, the blood pressure dropped down sharply due to massive haemorrhage and the patient expired.The reason was reportedly uncertain.
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