W. L. GORE & ASSOCIATES, INC. GORE® DRYSEAL FLEX INTRODUCER SHEATH; INTRODUCER, CATHETER
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Catalog Number DSF2233 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Thromboembolism (2654); Vascular Dissection (3160)
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Event Date 04/18/2022 |
Event Type
Injury
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Manufacturer Narrative
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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.¿.
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Event Description
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On april 18, 2022, the patient underwent emergency endovascular treatment of a ruptured thoracic aortic aneurysm using two gore® tag® conformable thoracic stent grafts with active control system.A 22fr gore® dryseal flex introducer sheath was used as an accessory during the procedure.It was reported the 22fr sheath was inserted from the right femoral artery.Access angiography after stent graft placement reportedly showed no issues, but echography at the time of wound closure confirmed weak flow to the peripheral.Access angiography was performed again and revealed an extensive localized dissection from the right common iliac artery to the right common femoral artery.A bare stent was implanted from the right common iliac artery to the puncture site of the common femoral artery to treat the dissection.After placement of the bare stent, thrombus formation or plaque shift was reportedly observed in the right superficial femoral artery.Thrombectomy was performed using a fogarty catheter.The patient tolerated the procedure.The physician commented that the patient's access vessel was narrow (measurement not available).According to the report, the thrombus formation/plaque shift occurred due to temporary peripheral ischemia caused by either insertion of the sheath, or thrombus dispersal from the aorta during tevar.
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Manufacturer Narrative
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H6: added health effect (clinical) and conclusion coding.
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Search Alerts/Recalls
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