The details indicate that the physician believes the patient had an allergic reaction to the graft.The device was discarded.As detailed in the adverse reaction section of the instructions for use swelling of tissue is a possibility.Swelling could occur if the patient was allergic to the eptfe.Based on the physician¿s comments it is likely that the patient was allergic to the ptfe.This cannot be confirmed however without actual patient testing.Based on the review of the complaint details provided by the physician, it is possible that the patient was allergic to the eptfe material of the graft.A review of the complaint history for all eptfe grafts going back a full 3 years based on the shelf life of the flixene grafts shows that there have not been any other reported incidents where a patient was allergic to the eptfe graft material.Clinical evaluation: an av graft is a looped, plastic tube that connects an artery to a vein.It is commonly used if the patient¿s veins are too small for an av fistula or if the patient¿s veins are blocked.Grafts can usually be used for dialysis within two to six weeks.Flixene eptfe vascular grafts are intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.The foreign body reaction begins as wound healing, including accumulation of exudate at the site of injury, infiltration of inflammatory cells to debride the area, and the formation of granulation tissue.The foreign body reaction is characterized by the formation of foreign body giant cells, encapsulation of the foreign object, and chronic inflammation.
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