The details indicate that a physician mentioned a hematoma with the patient that had a flixene implanted.The physician did not think it was a problem with the graft but there was an issue at the anastomosis when she re-intervened on the patient¿s swollen arm.As there were no images provided the cause of the hematoma is difficult to determine.Hematomas are listed within the adverse reactions section of the instructions for use.The physician mentioned that there was an issue at the anastomosis when intervened on the patient¿s swollen arm.It is possible that the connection to the vein or artery was not sufficient to prevent bleeding causing a hematoma.Additional information received stated that the hematoma was post-operative day 3.The first cannulation of the graft was performed on week 1 and has been cannulated since the implantation 3 times per week.There have been no complications reported since the cannulation.A thorough review of the device history records for this graft lot was conducted.The device lot in question met all quality and performance testing requirements and no non-conformance were noted during the build of the product related to the complaint.Based on the review of the device history records and product complaint details atrium medical corporation cannot conclude that the hematoma was directly related to the flixene graft.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 a hematoma is an abnormal collection of blood outside of a blood vessel.It occurs because the wall of the blood vessel wall, artery, vein, or capillary, has been damaged and blood has leaked into tissues where it does not belong.The instructions for use (ifu) states tunnel forming instruments should be sized to closely match the graft diameter to prevent formation of an oversized tunnel.An oversized tunnel may be a contributing factor in peri-graft seroma formation, hematoma and swelling, and may delay or interfere with peri-graft tissue attachment and healing.The ifu also states dialysis cannulation through this graft may be instituted with caution, so long as safeguards are taken to prevent or minimize hematoma formation, pseudoaneurysm, infection and/or material disruption requiring surgical intervention and vascular access puncture sites must be adequately separated as multiple punctures in the same area may lead to disruption of the graft material and formation of a peri-graft hematoma or pseudoaneurysm requiring surgical inter.
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