This report captures details related to patient 2 of 2.Refer to mdr-2247686-2021-00002 for details on patient 1.A review of the device history record for product batch 20l379 was re-reviewed and no related nonconformances were identified.The lot generated passing results for sterility testing prior to release to finished goods.The complaint artegraft was not returned for evaluation.In the initial follow-up conversation, the surgeon stated that the there was nothing wrong with the packaging boxes, the grafts were prepped according to recommendation.Additional information was requested; including relevant patient medical history/medications/preexisting conditions, and lab results; the information was not provided to date.No confirmed complaint trend was identified related to the issue.To date, no additional complaints were reported from the product batch 20l379.Artegraft® collagen vascular graft instructions for use (ifu, ls 012 rev.S) dosage and administration section provides instructions for aseptically removing the artegraft from its container.Additionally, the adverse effects section states "disruption of anastomoses, especially in the presence of infection, has been observed and, in a few cases, transient low grade fever, the etiology, of which has not been obvious, has been experienced." a definitive root cause was not established.All product quality and clinical issues will continue to be monitored within quality assurance trending.
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