(b)(4).The 26 fr gore® dryseal flex sheath is intended for insertion into an external iliac artery with a minimum outside diameter of 9.5 mm, as it was reported the patient¿s right external iliac artery measured 6.5 ¿ 7.0 mm in diameter, the 26 fr sheath was oversized and therefore use was outside of ifu.
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The following information was reported to gore through the pivotal study for the gore® tag® thoracic branch endoprosthesis (tbe device): on (b)(6) 2018, the patient underwent endovascular treatment of a 55 mm descending thoracic aortic (zone 2) aneurysm, distal to the left common carotid artery ostium and proximal to the left subclavian artery, with two gore® tag® thoracic branch endoprostheses.According to the report, the left subclavian artery was the intended branch vessel to be treated.Successful access and delivery to the intended implantation site and retrieval of the device delivery system was reported.A spinal drain was reportedly placed to prevent paraplegia.Reportedly, during withdrawal of the 26 fr gore® dryseal flex sheath, minimal resistance was noted.It was reported, intra-operative imaging revealed the right external iliac artery, measuring 6.5-7.0 mm in diameter, had ruptured.The physician reported the iliac artery was minimally calcified and tortuous.Blood loss of 400 ml.Was reported and a transfusion of 500 ml of blood products was administered.According to the report, an iliac extender component and two gore® viabahn® endoprostheses were implanted into the right external iliac artery and the rupture was reported to have been resolved without sequelae.Final angiography confirmed exclusion of the aneurysm, repair of the rupture, and full patency of all devices.The procedure was concluded with no further adverse events reported and the patient tolerated the procedure.
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