W. L. GORE & ASSOCIATES, INC. GORE® DRYSEAL FLEX INTRODUCER SHEATH; INTRODUCER, CATHETER
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Catalog Number DSF2033 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Vascular Dissection (3160)
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Event Date 04/17/2022 |
Event Type
Injury
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Event Description
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On (b)(6) 2022, a patient underwent emergency endovascular treatment of an infected thoracic aortic aneurysm using a gore® tag® conformable thoracic stent graft with active control system, and a 20fr gore® dryseal flex introducer sheath.During the treatment, the 20fr sheath was inserted from the right external iliac artery.According to the report, resistance was felt when the sheath was inserted into access vessel.The gore® tag® device was successfully implanted, however, a delayed proximal type i endoleak was reportedly observed.No touch up or other further treatment was performed, and the physician elected to monitor the endoleak.After the sheath was removed, decreased blood flow was reportedly observed.An intra-operative angiograph revealed an access vessel dissection.An additional stent graft was implanted to treat the dissection.The procedure was concluded without any further reported complications, and the patient tolerated the procedure.The physician commented that the patient¿s right external iliac artery was both fragile and narrow (measurement not available), and the dissection may have occurred due to sheath insertion maneuvers inside the narrow vessel.
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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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