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	Unspecified Infection (1930)
Date of Event	10/30/2019
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 06/11/2019 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 confirmed that "all devices met specification." the instructions for use supplied with the vascular product (art-20708a) was reviewed.Under the section 'potential complications', it states in part: "the following complications are possible.If any of these conditions occur, the vascure should be removed.Infection".The exact cause of the reported event cannot be conclusively determined but is a known potential complication.
Event or Problem Description
It was reported that a carotid endarterectomy was performed on (b)(6) 2019.The vascure was soaked for less than one minute in saline and was sewn to patient tissue.The patient required surgical intervention and was re-operated on (b)(6) 2019 to resolve what was described as a "blow out of the aziyo carotid patch".The probable cause of the event per the physician was infection; the patient tested positive for gram negative infection (staph schleiferi and staph hominis).The vascure product was explanted and replaced with a bovine patch.

• 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: 9404964
• Report Number: 3005619880-2019-00013
• Device Sequence Number: 2230809
• Product Code: DXZ
• UDI-Device Identifier: 10859389005147
• UDI-Public: 10859389005147
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: distributor,health profession
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/03/2019

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: 09/30/2020
• Device Model Number: CMCV-014-609
• Device Lot Number: M19F1240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 12/03/2019
• 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: 72 YR