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

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

Patient Problem Arrhythmia (1721)

Event Type  Injury  

Manufacturer Narrative

Manufacturing review of the cormatrix ecm for cardiac tissue repair device history record could not be completed as the lot/serial number was not provided.It is noted that the reported complication associated with arrhythmia is associated with the surgical procedure and not related to the aziyo device.Although the exact cause of the reported issues cannot be conclusively determined, arrhythmia is a known complication associated with the cavsd surgical procedure.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 retrospective single center study report published in the world journal of pediatric and congenital heart surgery titled "repair of complete atrioventricular septal defects with decellularized extracellular matrix: initial and midterm outcomes" was reviewed.This article provides the results of fifteen (15) patients who underwent surgery for a two-patch complete atrioventricular septal defect (cavsd) between april 2010 and july 2014 using the cormatrix (now aziyo biologics) extracellular matrix material.This report is focused on patient #15 (per publication table 1: patient demographics and echocardiographic data) for a 153 day old male who underwent cavsd repair with an unspecified piece of cormatrix ecm, likely cormatrix ecm for cardiac tissue repair (now aziyo biologics model #: unknown, lot#: unknown).At an unknown period of time post-op (mean follow-up stated as 1364 days with no range), the patient developed arrhythmia which was managed medically.The article states that no permanent pacemakers were required and that all post-operative complications in the study were nonpermanent and only required management in the immediate postoperative period.Attempts to contact corresponding author have been unsuccessful for any additional information.Should any additional information be received a follow-up report will be filed.

• Brand Name: CORMATRIX ECM FOR CARDIAC TISSUE 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: 10816135
• MDR Text Key: 215498750
• Report Number: 3005619880-2020-00066
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• 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
• Date Manufacturer Received: 11/08/2018
• 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