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

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

Patient Problem Aneurysm (1708)

Event Type  Injury  

Event Description

Surgeon reported adverse event as follows: female patient received aziyo ecm vascure (6-ply) for a carotid endarterectomy repair.At one month post-op, patient came in for a follow up and there were no issues per ultrasound assessment.The patient was then lost to follow-up.At 6 months post op., the patient saw her cardiologist who reported to surgeon that there might be a carotid aneurysm.Upon incision to repair the site, surgeon noted that the aneurysm was in the "exact location of the patch".The patch was excised and sent to pathology.Pathology confirmed "no infection" and findings were "unremarkable".Aneurysm site was repaired with another means (not another ecm patch).Because of the location of the aneurysm, surgeon would classify this adverse event as probably related to the patch (vascure device).Patient is doing well now.No date of event, implant or explant provided.No model number or lot number provided.

Manufacturer Narrative

Review of the manufacturing lot history record could not be completed, as the model and lot number were not provided.No explanted product sample was returned for evaluation.Attempts to contact the physician for more information went unanswered.The event report specifies that the aneurysm occurred in the "exact" location of the aziyo patch.The patch had been in place for six months before this event occurred, with no issues noted prior.However, the reported pathology of the patch noted "no infection" and the findings were "unremarkable".Therefore, it is possible the aneurysm was not in the patch itself but at the margin of the patch where it was attached to the patient's tissue or near the vicinity of the patch.The formation of the aneurysm at the margin of the patch could have multiple causes.These include patch not sewn to viable tissue, use of glues or gels, use of resorbable sutures, overhydration of the patch causing loss of integrity, inappropriate-sizing of patch, or lack of expected remodeling of the patch.All listed as "warnings and precautions" or "potential complications" in the instructions for use.There was no report of delamination or any other issue.The patch was located in a vessel of arterial pressure so any anomaly of technique or difficulty in healing could cause the aneurysm.It is noted that per the instructions for use, "aneurysm" is listed as a potential complication with the use of this device.

Manufacturer Narrative

Review of the manufacturing lot history record could not be completed, as the model and lot number were not provided.No explanted product sample was returned for evaluation.Attempts to contact the physician for more information went unanswered.The pathology report was also unavailable for review.The event report specifies that the aneurysm occurred in the "exact" location of the aziyo patch.The patch had been in place for six months before this event occurred, with no issues noted prior.However, the reported pathology of the patch, per physician description, included "no infection" and the findings were "unremarkable".Therefore, it is possible the aneurysm was not in the patch itself but at the margin of the patch where it was attached to the patient's tissue or near the vicinity of the patch.The formation of the aneurysm at the margin of the patch could have multiple causes.These include patch not sewn to viable tissue, use of glues or gels, use of resorbable sutures, overhydration of the patch causing loss of integrity, inappropriate-sizing of patch, or lack of expected remodeling of the patch.All listed as "warnings and precautions" or "potential complications" in the instructions for use.The patch was located in a vessel of arterial pressure so any anomaly of technique or difficulty in healing could cause the aneurysm.It is noted that per the instructions for use, "aneurysm" is listed as a potential complication with the use of this device.

• 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
• MDR Report Key: 15351428
• MDR Text Key: 299210721
• Report Number: 3005619880-2022-00017
• Device Sequence Number: 1
• Product Code: DXZ
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 09/02/2022
• Supplement Dates Manufacturer Received: 08/11/2022
• Supplement Dates FDA Received: 09/14/2022
• 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
• Patient Age: 75 YR
• Patient Sex: Female