Manufacturing review of the aziyo biologics device/lot history record for the reported lot shows that all units were quality released to finished goods on 6/3/2015 having met all internal qc acceptance requirements and met criteria for manufacturing release.There were no non-conformances associated with the manufacturing lot.A review of the complaint log shows that there are no complaints associated with this lot number except this one.An oem supplier review of sublots was completed and the review confirms that all devices met specifications.Instructions for use with the cormatrix ecm for cardiac tissue repair state (part # 20462-062014) under the section potential complications: acute or chronic inflammation, allergic reaction, reformation of intracardiac defect.On 7/9/2019 it was clarified that the event of recurrent central aortic insufficiency (reformation of intracardiac defect) that occurred was three (3) years post implant and the occurrence of delamination of the ecm material was thought to be in relation to the patient comorbidities and bought the patient more time before the next procedure.Both physicians were satisfied with the outcome and the request for histology is to see how much remodeling occurred.The original procedure was a partial replacement/patch of the aortic valve.Histologic impression: "partially remodeled ecm valve leaflet with mineralization; and chronic inflammation associated with a nidus of unremodeled ecm scaffold material." although the exact cause of the reported event cannot be conclusively determined, acute or chronic inflammation, allergic reaction, and reformation of intracardiac defect are known potential complications with the cormatrix ecm for cardiac tissue repair.Additionally, ecm material has a well-established acceptable iso 10993-1 biocompatibility test results profile meeting all iso 10993-1 guidelines.It can also be noted that per the site the patient has dysplastic aortic valve which could have contributed to the event.
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