MAUDE Adverse Event Report: AZIYO BIOLOGICS, INC. PROXICOR FOR CARDIAC TISSUE REPAIR; PATCH, PLEDGETT-INTRACARDIAC -DXZ

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

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 12/23/2021

Event Type  Injury  

Manufacturer Narrative

No samples were returned for evaluation by the aziyo pathology lab.No lhr review was possible as no model/lot numbers were provided.Two of the slides showed samples of explants obtained at 1 and 10 months--however, none of the reported patients had explants at that time.The report shows that all four patients had chronic inflammation, both in the graft and in the surrounding tissue.The authors noted that some of their samples showed a more significant inflammatory response in the area surrounding the sutures.It is not clear which sample is associated with which patient.The authors concluded that their results showed "time-dependent changes with some remodeling occurring in all samples." however, they did not find remodeling into tissue "similar to the three-layered native mitral valve" in the removed samples.It is noted that, per the instructions for use provided with the finished cormatrix ecm for cardiac tissue repair devices at the time of these events, this product is indicated for the following usages: intracardiac repair, patch or pledget for tissue repair (i.E., atrial septal defect, ventricular septal defect, etc.) and for suture-line buttressing.The ifu further provides a warning/ precaution that the device must be "sutured to viable native tissue", which would exclude leaving a "free-edge" to simulate the commissural closure of the valve cusps.The use of the ecm product to create an anterior leaflet would be an off-label use of this product.It is also noted per the ifu that potential complications include "acute or chronic inflammation" and "reformation of intracardiac defect".The exact cause and extent of the recurrent mitral regurgitation cannot be determined.Inflammation was present in all samples but correlation to regurgitation cannot be made.Therefore, the relationship between the device and the reported event cannot be conclusively determined.The surgeon's suturing technique and the type of sutures used cannot be excluded as contributing to these events.The authors stated that the underlying cause for all mitral valve regurgitation cases was hypertension.

Event Description

During post market surveillance, review of the publication entitled "pathological changes of adult mitral valves after failed cormatrix ecm repair" (j clin transl pathol.2021;1(1):9-15) was reviewed and summarized as follows: single site, retrospective study of 25 patients who had surgery between 2011 to 2014 which included a cormatrix (most likely aziyo product renamed proxicor for cardiac tissue repair) mitral valve anterior leaflet augmentation repair.Twenty-one (21) patients had an uneventful clinical course.Four (4) patients had severe mitral regurgitation "associated with graft failure" 4 - 12 months post procedure and had surgical reintervention."graft failure" was defined as patients that had evidence of severe mitral regurgitation on follow-up echocardiography regardless of symptoms.This study evaluated the pathological changes in the four explants.Histology showed ecm degradation in cases that "failed" as well as signs of remodeling.The four patients are described as 62 years old +/-13.3 years old.There was one female and three males.All four had a common history of hypertension.The authors stated that the underlying cause for all mitral valve regurgitation cases was hypertension.Model and lot numbers were not available.Attempts to contact the authors were unsuccessful.A spreadsheet is attached to represent the four patients who had recurrent regurgitation and required reoperation.

• Brand Name: PROXICOR FOR CARDIAC TISSUE REPAIR
• Type of Device: PATCH, PLEDGETT-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: 14193120
• MDR Text Key: 293562302
• Report Number: 3005619880-2022-00011
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• 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: 03/31/2022
• 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