We have received the complaint device for evaluation.However, we were unable to confirm the reported defect with the graft during our evaluation process.Graft was implanted in the patient's arm for av access on (b)(6) 2020.On (b)(6) 2020, surgeon observed a blood clot in the graft during an ultrasound scan.Graft was then explanted on (b)(6) 2020 and was replaced with another lifespan eptfe vascular graft.The occlusion occurred prior to any cannulation for av access.There was no injury to the patient as the result of this incident.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.Our ifu properly warns users about the risks which may occur in conjunction with the use of any vascular prosthesis including thrombosis.As stated in the ifu, complications due to individual patient reaction to an implanted device, or to physical or chemical changes in the components, may necessitate reoperation and replacement (sometimes within hours or days) of the prosthetic device.Careful and continuous medical follow-up is advised so that prosthesis-related complications can be diagnosed and properly managed to minimize danger to the patient.
|