No sample was returned for evaluation.Manufacturing review of the referenced lot number and respective device history record was conducted on 28-jan-2021, showing that all units were quality released on 13-aug-2021 having met all internal qc acceptance requirements.There were no non-conformances associated with the manufacturing lot during the final packaging.The sterile subassembly lot was also reviewed for potential issues impacting the quality of this product.This subassembly lot was released to component inventory, having met all quality requirements including product sterility testing following eo sterilization, as well as internal bioburden and product pyrogen (lal) testing requirements.In lieu of a request for the oem supplier for a dhr review of the ecm material lots, it is noted that aziyo processes the non-sterile envelope materials by cutting, suturing, packaging, and sterilizing.The physician reported that the patient pulled on the internal suture of the incision line of the pocket.It is also noted that per the instructions for use (ifu - art-20828a) provided with the finished cangaroo envelope device, infection is listed as a potential complication associated with this procedure and device usage.Should aziyo receive any additional information, a supplemental report will be filed.
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Email was received from the aziyo clinical research manager regarding a patient in an (b)(6) study.It was reported that on (b)(6) 2021, the patient had a de novo pacemaker implant with the implant of an aziyo cangaroo envelope (model cmcv-009-med, lot m21h1305).On (b)(6) 2021, site became aware that the patient developed an infection in the pocket and was treated with oral antibiotics (minocycline for 10 days) and event resolved without sequelae by (b)(6) 2021.Physician noted that patient pulled on internal suture, potentially opening the pocket.No further details are available regarding this event but if aziyo receives more information, a supplemental report will be filed.
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