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

Model Number CMCV-013-609

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Thrombus (2101)

Event Date 09/14/2019

Event Type  Injury  

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 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
• Type of Device: VASCURE FOR VASCULAR REPAIR
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• Manufacturer (Section G): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• Manufacturer Contact: andrew green ; 1100 old ellis road; ste 1200; roswell, GA 30076
• MDR Report Key: 9315072
• MDR Text Key: 166946914
• Report Number: 3005619880-2019-00011
• Device Sequence Number: 1
• Product Code: DXZ
• UDI-Device Identifier: 00859389005140
• UDI-Public: 00859389005140
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: CMCV-013-609
• Device Lot Number: M19E1184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention