Analysis: the graft in question was returned for evaluation and examined.The outer layer of the graft was fraying.The ptfe ring had been pulled and the outer soft wrap had begun to fray.As specified in the instructions for use: ¿if the external support rings are pulled too quickly, it is possible for a small portion of the vxt outer wrap to be removed.Should the outer wrap fray, the physician is still left with the base layer, which will be sufficient to complete the procedure.¿ a device history record review was performed and the graft lot was found to have met all specifications.While the rings are added to the advanta vxt to improve kink, compression and torque resistance, a physician may choose to remove portions of it for surgical/technical reasons.The instructions for use (ifu clearly define the appropriate steps of removing the helix.Hold the graft flat (horizontal).Take the very distal portion of the ptfe ring with a pair of forceps and slowly pull off the ring at a 45 degree angle.Being mindful not to catch the outer soft wrap.If he external support rings are pulled too quickly, it is possible for a small portion of the vxt outer wrap to be removed.Should the outer wrap fray, the physician is still left with the base layer, which will be sufficient to complete the procedure.Clinical evaluation: an arterio-venous (av) graft is a looped, synthetic tube that connects an artery to a vein.Advanta eptfe vascular grafts are intended for use in arterial vascular reconstruction, segmental bypass, and for arterio-venous vascular access.A graft may delaminate due to incorrect length, excessive tension or if implanted in a location that has excessive movement.The ifu states that the advanta vxt crafts should only be cut and trimmed with sharp surgical instruments to avoid reinforcement layer disruption.
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