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 No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Manufacturing review of the cormatrix ecm for cardiac tissue repair device history record(s) could not be completed as the lot/serial number(s) were not provided.It is noted that the instructions for use provided with the proxicor ecm for cardiac tissue repair (art-20700b) lists acute or chronic inflammation, undesired remodeling (e.G., poor tissue integration etc.) as potential complications associated with use of this device, or with any surgical implant procedure.No further details were provided in the published literature relating to these events and attempts to contact corresponding author have been unsuccessful at the time of this report.Should aziyo receive any additional details related to these events, a supplemental report will be filed.

Event Description

As part of the post market surveillance process, this single center, single surgeon retrospective clinical review of norwood palliation procedures published in the annals of thoracic surgery titled "porcine small intestinal submucosa may be a suitable material for norwood arch reconstruction" was reviewed.This article summarizes the results of forty-four (44) pediatric patients with single-ventricle anatomy undergoing a norwood palliation with interdigitating arch reconstruction using a porcine small intestinal submucosa (psis) extracellular matrix from cormatrix cardiovascular, now aziyo biologics.The specific material is not referenced, but cormatrix ecm for cardiac tissue repair would be indicated for these types of heart repair.The review spanned the period of 2/2011 through 1/2015.The cormatrix ecm for cardiac tissue repair was utilized to complete the construction of the neoaorta and the systemic to pulmonary artery shunt.In addition the ecm was used for the distal main pulmonary artery patch.The conducted review of this study cohort defined reinterventions as those specific to the reconstructed neoaortic arch and monitored patient "interstage" survival.As the norwood procedure is the initial palliation for hypoplastic left heart syndrome (hlhs) providing survivability to the second phase (bi-directional glenn (bdg) procedure), and finally to the fontan procedure and/or heart transplant; reintervention in this study was defined as intervention within the "interstage" period.Of the forty-four (44) patients reviewed, there were five (5) patients who ultimately received heart transplants.Of those 5 patients, explanted psis - ecm material was available following 1 transplant.The patient age at time of transplant was 9 months and evaluation of the explanted tissue stated that it demonstrated chronic inflammation and fibrosis.No further details specific to histological analysis were provided.Attempts to contact the corresponding author have been unsuccessful at the time of this filing for additional information 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 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
• MDR Report Key: 11100273
• MDR Text Key: 224528726
• Report Number: 3005619880-2020-00111
• 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: 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): Other
• Patient Age: 9 MO