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

Model Number	CMCV-014-609
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Thrombosis (2100); Pseudoaneurysm (2605)
Date of Event	07/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review of the device history record for the reported lot shows that all units were quality released on 4/24/2015 having met all internal qc acceptance requirements.There were no non-conformances associated with the manufacturing lot during production and final packaging.Oem supplier reviewed the sub-lots associated with the reported lot and it was stated that, "no deviations or nonconformance's were found to be associated with the lots.The review confirms that all devices met specification." the instructions for use with the vascular product (part number 20438-032514) was reviewed.Under the section potential complication, it states: "the following complications are possible.If any of these conditions occur, the cormatrix ecm should be removed: pseudoaneurysm, thrombosis, stroke." the exact cause of the reported event cannot be conclusively determined but are known potential complications.
Event or Problem Description
It was reported that during a carotid endarterectomy the ecm for vascular repair was used in the carotid artery on (b)(6) 2015.The patient was a (b)(6) year-old male with no listed comorbidities.The ecm was soaked for less than 1 minute in saline and was secured to the patient's tissue with a 6-0 prolene suture.On (b)(6) 2019 there was a large pseudoaneurysm of patch with thrombosis and stroke (embolic) symptoms.As of (b)(6) 2019 the treatment of the patient is to be determined but listed possible intravascular stent.The doctor states that the event is "definitely related" to the device.

• Brand Name: CORMATRIX ECM FOR VASCULAR 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: 8908117
• Report Number: 3005619880-2019-00009
• Device Sequence Number: 16827063
• Product Code: DXZ
• UDI-Device Identifier: 10859389005147
• UDI-Public: 10859389005147
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K140789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2019

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: 07/31/2016
• Device Model Number: CMCV-014-609
• Device Lot Number: M15D1104
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 08/19/2019
• 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: Life Threatening; Required Intervention
• Patient Age: 64 YR