MAUDE Adverse Event Report: AZIYO BIOLOGICS, INC. CORMATRIX ECM FOR CAROTID REPAIR; PATCH, PLEDGET, INTRACARDIAC - DXZ

Device Problem Thickening of Material (4056)

Patient Problem Restenosis (4576)

Event Type  Injury  

Manufacturer Narrative

Manufacturing review of the cormatrix ecm for carotid repair device history record could not be completed as the lot/serial number was not provided.It is noted that per the instructions for use (ifu - art-20702) provided with the finished vascure for carotid repair device that stenosis/restenosis is listed as a potential complication associated with the procedure and device.Although the exact cause of the reported issues cannot be conclusively determined, stenosis is a known complication associated with the use of a cormatrix ecm for carotid repair and a surgical implant procedure.No further details are available at this time, should aziyo receive any additional details related to this event, a supplemental report will be filed.

Event Description

As part of the post market surveillance process, this single center study report published in journal of vascular medicine & surgery titled "effect of extracellular matrix patch on femoral artery after endartarectomy" was reviewed.The article summarizes the results of four (4) patients with peripheral artery disease (pad) involving stenosis of the common femoral artery with bifurcation.The specific product or size is not provided in the article, however likely treated with cormatrix ecm for carotid repair.Of the four patients treated, one (1) patient died two (2) days post-op due to cardiac arrest and reported in a separate mdr.The remaining three (3) patients were evaluated at one, three, and six months post-operatively with no reported complications.At one year post-op, one (1) patient was identified with restenosis.This report will focus on the restenosis event.This patient (patient #3 of the study group) who initially presented with stenosis in the distal portion of the external iliac artery (eia) prior to the surgical procedure, now showed restenosis of the eia.Marginal wall thickening of the ecm and significant restenosis was shown by spectral doppler.Both the common and profunda femoral arteries continued to demonstrate patency.Follow-up attempts to contact the corresponding author have been unsuccessful and no details have been provided regarding specific product used and corresponding lot numbers.Should any additional information be received a follow-up report will be filed.

• Brand Name: CORMATRIX ECM FOR CAROTID 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: 11084448
• MDR Text Key: 231785903
• Report Number: 3005619880-2020-00081
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: K111187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 12/28/2020
• 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