MAUDE Adverse Event Report: AZIYO BIOLOGICS, INC. CORMATRIX ECM FOR CARDIAC TISSUE REPAIR; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Model Number	CMCV-004-401
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Aortic Insufficiency (1715); Foreign Body Reaction (1868); Inflammation (1932)
Date of Event	06/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that a male patient underwent a complex aortic valve repair on (b)(6) 2016.The cormatrix ecm for cardiac tissue repair was soaked in a saline solution for 1 minute.On (b)(6) 2019 (patient reported as (b)(6) years old at time of event) due to recurrent central aortic insufficiency he needed to be re-operated for a ross procedure.A replacement of the aortic valve with pulmonary autograft was completed.It can be noted that the patient has dysplastic aortic valve and could have contributed to the event.Probable cause of the event was listed as delamination of the ecm causing calcification and leaflet immobility.The site states that the event is probably related to the procedure and probably related to the ecm device.The 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 (ross).The physicians were satisfied with the outcome.

• Brand Name: CORMATRIX ECM FOR CARDIAC TISSUE REPAIR
• Common Device Name: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• MDR Report Key: 8870610
• Report Number: 3005619880-2019-00008
• Device Sequence Number: 189125
• Product Code: DXZ
• UDI-Device Identifier: 10859389005048
• UDI-Public: 10859389005048
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: CMCV-004-401
• Device Lot Number: M15F1133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 08/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 YR