On (b)(6) 2021, the patient underwent emergency endovascular treatment of a thoracic aneurysm rupture using two gore® dryseal flex introducer sheaths as accessories during the procedure.According to the report, the insertion site of the right femoral artery was damaged upon insertion of the 24fr sheath.An artificial blood vessel was placed to replace the damaged femoral artery.The patient tolerated the procedure.It was reported that both access vessels were narrow and stenosed (minimum diameters are about 5-6mm in both right/left access arteries).Calcium was also reportedly seen in both vessels.Percutaneous balloon angioplasty was needed to insert the sheath on both sides.
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(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 (8.8mm for a 24fr sheath), major bleeding, vessel damage, or serious injury to the patient, including death, may result.
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