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	06/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Email received from sales rep: "patient presented 10 years after initial surgery [for carotid repair with vascure] with asymptomatic pseudoaneurysm 2.5cm.During a modified tcar (transcarotid artery revascularization) procedure, a stent was placed through a catheter; vascure patch was not removed." pseudoaneurysm described as on the edge of patch and not in the middle.Physician stated that he was not sure it had anything to do with aziyo patch but considered this "atypical" and "consistent with long term patch data that patches can become aneurysmic".Patient had no reported comorbidities and is doing well.
Additional Manufacturer Narrative
The specific cause of the pseudoaneurysm cannot be conclusively established.The site was not reopened and the implant remained in place.The physician was not able to identify if the pseudoaneurysm was at the margin of the original implant as opposed to in the same arterial site.The original surgery itself, with the opening of the artery and the placement of a patch, which is sutured to the patient's native tissue, could have contributed to the event.The fact that the patch was in place for ten years, in a high flow, high-pressure location could have contributed to the failure of the patch to completely remodel or for the anastomosis (suture) to fail over time.However, it is more likely that this was not a patch failure, as the patch should have been fully remodeled in the ensuing ten years."pseudoaneurysm" is a known potential complication associated with the use of the patch and is reflected in the instructions for use, distributed with the vascure for vascular repair device.

• 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
• 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
• MDR Report Key: 15714373
• Report Number: 3005619880-2022-00018
• Device Sequence Number: 17374397
• Product Code: DXZ
• UDI-Device Identifier: 00859389005140
• UDI-Public: 00859389005140
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K140789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male