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

Device Problem Thickening of Material (4056)

Patient Problems Pericardial Effusion (3271); Pericarditis (4448)

Event Type  Injury  

Manufacturer Narrative

Manufacturing review of the cormatrix ecm for pericardial closure 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-20701b) provided with the finished proxicor for pericardial closure device, that the potential complications provided lists acute or chronic inflammation, cardiac tamponade and mediastinitis.No time frame is reported for the onset of pericardial constriction in the letter to the editor.Inflammation, or potential for cardiac tamponade due to suturing device into place is a known risk for usage of this product as well as within any cardiac surgical procedure.Although the exact cause of the reported event cannot be conclusively determined, the event is a known complication associated with a valve replacement/open heart surgical 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 letter to the editor summarizes the results of eight (8) patients whom were implanted with cormatrix patches (product and size not specified, but likely cormatrix ecm for pericardial closure) as a pericardial substitute in these patients with valve disease in which surgery was second or third intervention.This study was a single center, single surgeon study presented in this letter to the journal of cardiovascular surgery titled "is cormatrix really a recellularization scaffold as a pericardial substitute in cardiac surgery?" the letter summarizes the usage of cormatrix ecm to close the pericardium of these patients having undergone unspecified valve disease surgery over the period from 2014 to 2015, and closed with an oversized piece of ecm using interrupted sutures for closure.None of the patients presented complications during the hospital stay and follow-up related to the patch except one.A (b)(6) yr-old male patient with history of valve disease, presented with symptoms and echocardiograph compatible with pericardial constriction.Cardiac mri revealed thickened prosthetic material with a maximum thickness of 19mm in the are of the large vessels, and slight posterior inferior pericardial effusion.The patient refused all surgical procedures, and was treated with anti-inflammatories and a cycle of corticosteroids.Evolution was favorable, patient is asymptomatic and lacking any echocardiographic signs of constriction at one year.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 PERICARDIAL CLOSURE
• 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: 11100628
• MDR Text Key: 231786734
• Report Number: 3005619880-2020-00083
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K051405
• 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: 12/31/2020

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: 11/08/2018
• Initial Date FDA Received: 12/31/2020
• 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
• Patient Age: 60 YR