MAUDE Adverse Event Report: AZIYO BIOLOGICS, INC. VASCURE FOR VASCULAR REPAIR

Model Number	CMCV-014-609
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	07/24/2019
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 05/08/2019 having met all internal qc acceptance requirements.There were no non-conformances associated with the manufacturing lot during production and final packaging.The oem supplier reviewed the sub-lots associated with the reported lot and confirms that "all devices met specification." the instructions for use with the vascular product (art-20708a) was reviewed.Under the section potential complication, it states: " the following complications are possible.If any of these conditions occur, the vascure should be removed.Hematoma, undesired tissue remodeling (e.G., poor tissue integration, excessive scar tissue formation, or rapid degradation of vascure)" the exact cause of the reported event cannot be conclusively determined but are known potential complications.
Event or Problem Description
It was reported that a carotid endarterectomy was performed on a male patient on (b)(6) 2019.The vascure was soaked for less than one minute in saline and was sewn with a 6-0 prolene to the patient's tissue.It was stated that "patient discharged home (b)(6) 2019 had discomfort in neck with hematoma, re-admitted (b)(6) 2019.Taken to surgery where ecm patch had "sloughed" away where suture wouldn't hold to vascure.Re-operation where vein patch was sewn into place after ecm was explanted.Patient returned to operating room where vein patch was explanted and a dacron patch was sewn in to replace." it can be noted that the patient had uncontrolled hypertension.Probable cause of the event was stated as "unsure".The patient was discharged on (b)(6) 2019 and is recovering at home.

• Brand Name: VASCURE FOR VASCULAR REPAIR
• Common Device Name: VASCURE FOR VASCULAR REPAIR
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• MDR Report Key: 9321242
• Report Number: 3005619880-2019-00012
• Device Sequence Number: 19463971
• Product Code: DXZ
• UDI-Device Identifier: 10859389005147
• UDI-Public: 10859389005147
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K140789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/14/2019

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: 07/31/2020
• Device Model Number: CMCV-014-609
• Device Lot Number: M19E1179
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 11/14/2019
• 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