(b)(4).It should be noted the gore® dryseal flex introducer sheath instructions for use (ifu) state ¿adequate vessel access is required to introduce the sheath into the vasculature.Careful evaluation of vessel size, anatomy, tortuosity, and disease state (including calcification, plaque, and thrombus) is required to ensure successful sheath introduction and subsequent withdrawal.If vessel is not adequate for access, major bleeding, vessel damage, or serious injury to the patient, including death, may result.¿ additionally, per ifu, if vessel size is smaller than the nominal body outer diameter, major bleeding, vessel damage, or serious injury to the patient, including death, may result.
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On (b)(6) 2021, the patient underwent endovascular treatment of a thoracic aneurysm using a 22fr gore® dryseal flex introducer sheath (nominal body outer diameter: 8.2mm) as an accessory during the procedure.The right access vessel measured a reported 6-7 mm in diameter, and there reportedly was stenosis in the right external iliac artery.Percutaneous transluminal angioplasty was performed with an 8 mm balloon before sheath insertion.During insertion of the 22fr sheath, resistance was reportedly felt at the right external iliac artery.The sheath was removed once and reinserted successfully.After stent graft implantation, access angiography reportedly showed vessel damage in the right external iliac artery.Two additional stent grafts were implanted to treat the damaged vessel.According to the report, a dissection was also observed in the common iliac artery (no further details regarding the dissection were available).The physician opted to take a wait-and-watch approach regarding the dissection, and the procedure was completed.The patient tolerated the procedure.
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