No sample was returned for investigation.Manufacturing review of the device history record could not be completed as the model number/lot number were not provided.The cormatrix (now aziyo biologics) proxicor for cardiac tissue repair was placed to reconstruct and reinforce the mitral-aortic intervalvular fibrosa (an anatomical wall) during a previous surgery.The authors state that biological glue was used on the suture line to arrest bleeding.Instructions for use (art-20706a) provided with the device state under the section "warnings and precautions", that the aziyo device is not recommended to be used with glue containing glutaraldehyde.In addition, the instructions for use provided with the proxicor for cardiac tissue repair (art-20706a) identifies as potential complications - dehiscence and pseudoaneurysm.
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During post-market surveillance, article entitled "multimodality imaging in the evaluation of ascending aortic pseudoaneurysms to guide complex surgical management", case: cardiovascular imaging case reports, october 2020, was reviewed and summarized as follows: (b)(6)-year-old man underwent three cardiac surgeries with several grafts and valve replacement procedures, one of which utilized a "cormatrix patch".While the specific cormatrix (now aziyo biologics) device was not specified, it was likely a proxicor for cardiac tissue repair (model #: unknown, lot #: unknown); selected due to type of repair performed - reconstruction of the mitral-aortic intervalvular fibrosa.Three years later, the patient developed dyspnea and chest pain.The patient was diagnosed with aortic root pseudoaneurysm at the graft site as well a pseudoaneurysm at the aortic valve anastomotic site.Upon reoperation, the patch used to reconstruct the intervalvular fibrosa during the patient's previous surgery was found to have necrosed, causing dehiscence of the patch.This led to a pseudoaneurysm which affected valve function and led to perfusion compromise.There were no signs of active infection.The patch was excised and the descending aorta and valve were again replaced, and the patient's post-op course was uneventful.Attempts to contact corresponding author of publication for additional information were unsuccessful.Should any additional information be received related to this event, a follow-up report will be filed.
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