MAUDE Adverse Event Report: AZIYO BIOLOGICS INC. VASCURE FOR VASCULAR REPAIR; PATCH, PLEDGET, INTRACARDIAC - DXZ

Model Number	CMCV-013-609
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	10/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review of the vascure for vascular repair device history record for the reported could not be completed as the lot/serial number was not provided.It is noted that per the instructions for use (ifu - (b)(4)) provided with the finished vascure for vascular repair device, (pseudo) aneurysm is listed as a potential complication associated with the procedure and device.Although the exact cause of the reported issues cannot be conclusively determined, (pseudo) aneurysm is a known complication associated with the use of a vascure for vascular repair and a surgical implant procedure.Should aziyo receive any additional details related to this event, a supplemental report will be filed.
Event or Problem Description
It was reported on 10/05/2020 by an aziyo sales representative that they were notified of an adverse event related to an implant of an aziyo vascure for vascular repair (model #: cmcv-013-609; lot #: unknown) performed in (b)(6) 2019 (exact date not reported - (b)(6) used for date of implant field) used in carotid endarterectomy.On (b)(6) 2020 the patient returned with a suspected pseudoaneurysm and underwent a procedure to remove repair.The surgeon reported that they found a blow out at the base of the patch and a sample was sent to pathology.Additional follow-ups with physician and sales representative provided no further information on the reported event.

• Brand Name: VASCURE FOR VASCULAR REPAIR
• Common Device Name: PATCH, PLEDGET, INTRACARDIAC - DXZ
• Manufacturer (Section D): AZIYO BIOLOGICS INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• MDR Report Key: 10784410
• Report Number: 3005619880-2020-00093
• Device Sequence Number: 4135255
• Product Code: DXZ
• UDI-Device Identifier: 00859389005140
• UDI-Public: 00859389005140
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2020

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 Model Number: CMCV-013-609
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 11/04/2020
• 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