We have not received the graft for evaluation since the graft remains implanted.Hence, we could not conclusively determine the cause of the failure.As this is a known possible issue, instructions for use include instructions for pressure testing each graft prior to implant.The preparation for implant section states, "artegraft is manometry pressure tested and quality inspected.Before implanting, occlude one end of graft and pressure test with syringe filled with saline solution." the preimplant pressure test required per the ifu was performed by the customer and did not identify any leaks with the graft.As the pre-implant pressure test did not identify any leaks and the graft was implanted for 23 days prior to the issue, it is likely that the issue was caused after the implant procedure.All grafts released from batch 21b048 passed the requirements for release, including pressure testing, sterility testing, and final visual inspection prior to release to finished goods.To date, no additional complaints were reported from this product batch.Based on our investigation this appears to be an isolated incident.All product quality and clinical issues will continue to be monitored within quality assurance trending.
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