On an unknown date, the patient underwent endovascular treatment of a thoracic aortic aneurysm using a non-gore manufactured stent graft.On (b)(6) 2021, the patient underwent endovascular treatment of thoracic aneurysm enlargement using a gore® tag® conformable thoracic stent graft with active control system.During the procedure, a 22fr gore® dryseal flex introducer sheath was inserted from the left femoral artery.According to the report, resistance was felt while advancing the sheath.The reason for the resistance felt while advancing the sheath was unknown.The diameter of the access vessel from the left femoral artery to the external iliac artery measured a reported 6.1mm to 8.2mm.After all gore® tag® devices were implanted, the left external iliac artery (eia) was reportedly ruptured upon removal of the sheath.A gore® viabahn® endoprosthesis (8mm x 10cm) was implanted with coverage of the left internal iliac artery to treat the left eia rupture.Distal bleeding was reportedly observed, and the physician opted to implant a second gore® viabahn® endoprosthesis (8mm x 5cm) distally.Procedural imaging reportedly revealed a suspected proximal type i endoleak, and a gore® viabahn® vbx balloon expandable endoprosthesis was then implanted proximally.It was reported that bleeding was also observed at the sheath insertion area.The gore® viabahn® endoprosthesis was clamped using a forceps (it was unknown whether the clamped area included the distal gore® viabahn® endoprosthesis, or the junction of the two gore® viabahn® devices).The area of sheath insertion was surgically repaired; however, the bleeding reportedly was not resolved.Additionally, blood flow was reportedly impaired distal to the midpoint of the proximal gore® viabahn® endoprosthesis.A femoro-femoral bypass was performed, and blood flow to both peripheral arteries was restored.The procedure was concluded, and the patient tolerated the procedure.The physician commented it was unknown whether the clamped gore® viabahn® endoprosthesis was related to the disappearance of blood flow in the device.It was reported that when the gore® viabahn® endoprosthesis was clamped, the device was compressed.Percutaneous transluminal angioplasty (pta) was performed, and the blood flow was reportedly observed at that time.However, the gore® viabahn® endoprosthesis was reportedly clamped several times, which may have contributed to the two gore® viabahn® devices becoming occluded.
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The gore® dryseal flex introducer sheath in this event has been reported in mfr report #3007284313-2021-01672.The 8mm x 10cm (proximal) gore® viabahn® endoprosthesis in this event has been reported in mfr report #2017233-2021-02559.Results pending completion of manufacturing evaluation.The device remains implanted and, therefore, was not available for direct analysis by gore.
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