On (b)(6) 2017, the patient underwent endovascular repair of an infectious descending thoracic aortic aneurysm and an abdominal aortic rupture.First, the physician implanted a conformable gore® tag® thoracic endoprosthesis to repair the descending thoracic aortic aneurysm.Next, the physician elected to implant gore® excluder® aaa endoprostheses featuring c3® delivery system to repair the abdominal aortic rupture.A trunk-ipsilateral leg component was advanced from the left side and its proximal portion was deployed.Then, a 14-fr gore® dryseal sheath with hydrophilic coating (dsl1428j/15472863) was inserted from the right side and cannulated into the contralateral gate.All the endoprostheses were deployed, and upon withdrawal of the introducer sheath, the right external iliac artery was ruptured.An iliac extender component was implanted in the ruptured area, and the patient tolerated the procedure.It was reported that resistance was met while the introducer sheath was being inserted from the right side.There existed calcium in the right iliac artery, which could have contributed to the external iliac artery rupture.
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The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the instructions for use (ifu) of the gore® dryseal sheath with hydrophilic coating, adverse events that may occur and / or require intervention include, but are not limited to vascular trauma (rupture).
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