Manufacturing review of the cormatrix ecm for cardiac tissue repair (now aziyo proxicor for cardiac tissue repair) device history record could not be completed as the lot/serial number was not provided.It is also noted that per the instructions for use (ifu - art-20700b) provided with the finished proxicor for cardiac tissue repair device, localized inflammation, patch dehiscence or rupture, or reformation of cardiac defect are listed as a potential complications associated with the procedure and device.In addition, the ifu for the proxicor for cardiac tissue repair device provides a warning/precaution that the device must be sutured to viable native tissue.Indicating that all edges of sutured ecm patch be made to viable tissue which would exclude leaving a "free-edge" to simulate the commissural closure of the valve cusps.Further, the ifu states under suggested instructions for implanting proxicor for cardiac tissue repair to "place the edge of the proxicor in contact with viable tissue." although the exact cause of the reported aortic insufficiency issue cannot be conclusively determined, localized inflammation, patch dehiscence or rupture, reformation of cardiac defect, are known complications associated with the use of a proxicor for cardiac tissue repair and this surgical implant procedure.Should aziyo receive any additional details related to this event, a supplemental report will be filed.
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As part of the post market surveillance process, this article / clinical case report published in xenotransplantation 2017;24:e12341 titled "congenital aortic valve repair using cormatrix: a histologic evaluation" was reviewed.This article reports a retrospective review of six (6) patients who underwent surgery for severe aortic valve stenosis (4 patients) or regurgitation (2 patients) between april and july 2013.Aortic valve repair was performed on all patients using decm cormatrix as a leaflet replacement or extension.This report is focused on patient #2 (per publication table 1: demographic and surgical details) where a (b)(6) mo.Old male with aortic stenosis underwent a bicuspidization partial replacement (50%) procedure of the left and right cusps with cut surface to the native cusp using cormatrix (now aziyo biologics) decm (model #: unknown [likely to be proxicor for cardiac tissue repair], lot #: unknown).Following operation patient demonstrated satisfactory results with grade 1 insufficiency and good mobility of the tissue observed at 1mo.At 2 years follow-up, insufficiency had increased to grade 2, and at 3 years progressed to grade 3 where reoperation was planned.Attempts to contact corresponding author have been unsuccessful for any additional information.Should any additional information be received a follow-up report will be filed.
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