Upon initial inspection the graft, the device exhibited shredding of the ptfe surface of the graft.The investigation confirmed that shredding of the surface of the graft was present when attempting to remove the helix wrap, however a root cause has not been determined.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 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.Clinical evaluation: the graft needs to be sized correctly prior to implant to ensure the integrity of the anastomosis sites.If a graft is too short there would be excessive tension at the suture sites and could potentially result in tearing or shredding.The instructions for use state complications may occur during the use of any vascular graft include mechanical disruption or tearing of the graft material which may result in adverse events.
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