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

Model Number CMCV-013-609

Device Problem Insufficient Information (3190)

Patient Problem Pseudoaneurysm (2605)

Event Date 10/05/2020

Event Type  Injury  

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 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
• Type of Device: PATCH, PLEDGET, INTRACARDIAC - DXZ
• 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: michael hennick ; 1100 old ellis road; ste 1200; roswell, GA 30076 ; 4705144023
• MDR Report Key: 10784410
• MDR Text Key: 214755800
• Report Number: 3005619880-2020-00093
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CMCV-013-609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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