(b)(4).All patients had esrd, arteriovenous fistula and symptomatic occlusion of the cephalic arch or subclavian vein.Hypertension = 100% of patients.5/9 had diabetes mellitus.Review of the manufacturing records could not be performed as no lot number information was provided.The device was not returned.Consequently, direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no conclusion can be drawn.
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The following article was reviewed: ¿percutaneous costoclavicular bypass for thoracic outlet syndrome and cephalic arch occlusion in hemodialysis patients¿; jeffery hull, m.D.And james snyder, m.D.A retrospective review of percutaneous costoclavicular bypass patients between november 2014 ¿ december 2017 was performed.Stent grafts were placed subcutaneously over the clavicle from the fistula outflow (axillary or cephalic vein) into a jugular vein or collateral.The fistula outflow was cephalic in 67% (6/9) and axillary in 33% (3/9).The return vessel was external jugular in 78% (7/9) and internal jugular in 22% (2/9).Two overlapping viabahn stent grafts were used in 88% of cases (7/8) and 3 stent grafts in 1 case.At 12 months and 24 months, primary patency was 67% and 67%, and secondary patency was 89% and 78%, respectively.Complications included late thrombosis and secondary infection.There were no anastomotic leaks or seromas associated with extravascular stent grafts.One viabahn stent graft was secondarily infected 5 months after placement.In this case, the stent was excised, and the cephalic vein was anastomosed to the axillary vein.
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