A review of the manufacturing records for the device could not be conducted as lot number of the device was not available.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 (dissection).
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This report captures the abdominal aortic dissection: on (b)(6) 2018, the patient underwent endovascular repair of a pseudoaneurysm that had been formed around distal anastomosis of a surgical graft in the aortic arch.A 22-fr gore® dryseal sheath with hydrophilic coating (dsl2228j/unknown lot number) was advanced from the right side and positioned distal to the inferior mesenteric artery.A delivery catheter for conformable gore® tag® thoracic endoprosthesis was then advanced through the sheath and deployed with its proximal end positioned inside the surgical graft.Upon withdrawal of the sheath, dissections were formed in two different locations: one was the retrograde abdominal aortic dissection originating from the abdominal bifurcation to the proximal abdominal aortic neck while the other was a localized dissection in the right external iliac artery.It was reported that vessel diameter of the right external iliac artery around the dissection site was 7.5mm.An intervention was performed whereby gore® excluder® aaa endoprosthesis, aortic extender components were implanted in the abdominal aorta to repair the dissection.However, a wait-and-watch approach was taken to the right external iliac artery dissection.The patient tolerated the procedure.
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