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

Model Number	CMCV-013-609
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Thrombus (2101)
Date of Event	09/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review of the device history record for the reported lot shows all units were quality released on 07 may 2019 having met all internal qc acceptance requirements.There were no nonconformances associated with the manufacturing lot during production and final packaging.Oem supplier reviewed the sub-lots associated with the reported lot and confirmed that "all devices met specification".The exact root cause of the event cannot be conclusively determined.The probable cause of the event is previous infection and the device may not have been sewn to viable tissue.
Event or Problem Description
The patient was admitted to the or for a re-do on an infected endarterectomy.Bovine patch was explanted and replaced using aziyo vascure on (b)(6) 2019.Both the bovine patch, femoral artery, bypass graph and surrounding tissue of the groin were badly infected.It was reported that on (b)(6) 2019 the vascure patch had disintegrated/dissolved, femoral artery had thrombosed and infection was present.Serratia marcescens was the confirmed pathogen.The serratia marcescens pathogen has been present multiple times (the patient was growing it when the vascure was implanted) with this patient and the patient's previous history.The physician was not sure if the vascure patch was sewn to viable tissue and that this could have contributed to the adverse event.The patient was reported as stable and healing.

• 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: 9315072
• Report Number: 3005619880-2019-00011
• Device Sequence Number: 10879775
• Product Code: DXZ
• UDI-Device Identifier: 00859389005140
• UDI-Public: 00859389005140
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: CMCV-013-609
• Device Lot Number: M19E1184
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2019
• 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