On (b)(6) 2019, the patient underwent endovascular treatment using gore® excluder® aaa endoprosthesis with gore® molding & occlusion balloon for abdominal aortic aneurysm.Reportedly the patient had pre-existing localized dissections in both the external iliac arteries.It was report that after deployment of gore® excluder® aaa trunk-ipsilateral leg endoprosthesis and contralateral leg endoprosthesis, an aortic extender endoprosthesis was deployed proximally.Touch up ballooning was then performed.It was reported that the contrast medium had flowed out of the blood vessel from the proximal neck, the aortic artery had ruptured at this area.To treat the rupture, four aortic extender endoprostheses were deployed on the proximal side.The outflow of contrast medium disappeared.After angiography, the blood flow to the left internal iliac artery was not confirmed.The possibility of occlusion of effects due to thrombosis was reported.Since blood flow to the right internal iliac artery was confirmed, the physician chose to monitor the left internal iliac artery occlusion.During closure of wound, the pulse in distal of right leg was weak.When angiography was performed, a dissection appeared to have occurred on the distal side of the stent graft, and blood flow in the right internal iliac artery could not be confirmed.It is unknown if the implanted device or the dryseal flex sheath was responsible for the additional dissection in the right iliac artery.In addition, angiography to below the knee was performed, the occlusion was confirmed.Two bare metal stents were implanted from the distal side of the stent graft to the right external iliac artery.After pta ballooning and passing wire and micro catheter below the knee, a slight blood flow was confirmed.The doctor stated "the no blood flow to the right internal iliac artery might be due to the dissection." the patient tolerated the procedure.
|
Addition h6: code 213-the review of the manufacturing paperwork verified that this lot met all pre-release specifications.Addition h6: code 22-the gore® molding and occlusion balloon catheter instructions for use, under adverse events states, trauma to the vessel wall, including rupture.
|