We have not received the graft for investigation.The patient received the graft on (b)(6) 2021 and it occluded on (b)(6) 2022.It could not be confirmed if the graft was accessed for hemodialysis during this period.We have sent a list of follow-up questions to the hospital but have not yet received a response.Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.Further, we have not received any other complaints of a similar nature for devices from this lot.Hence, we consider this to be an isolated incident.Graft incorporation involves the graft becoming densely fibrosed to soft tissues so that when needle cannulation is performed there is no potential space for hematoma formation.As stated in the ifu, we recommend using a tunneler to create a tissue tunnel that closely approximates the graft diameter.An oversized tissue tunnel may result in delayed or insufficient perigraft tissue attachment and may promote perigraft seroma formation.The ifu also properly warns users about life-threatening complications which may occur in conjunction with the use of any vascular prosthesis include, but are not limited to excessive suture hole bleeding, thrombosis, thromboembolic complications, infection, ultrafiltration or perigraft seroma, swelling of limbs, pseudoaneurysms, perigraft hematomas, skin erosion, steal syndrome, preoperative hemorrhage, aortoenteric fistula.
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