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

Device Problem Insufficient Information (3190)

Patient Problems Stenosis (2263); Obstruction/Occlusion (2422)

Event Date 05/30/2018

Event Type  Injury  

Manufacturer Narrative

No details were provided in the published literature regarding the specific cormatrix ecm (dpsis) product used.However, based on the reported usage, the indications for use most closely match the aziyo product proxicor for cardiac tissue repair (formerly cormatrix ecm for cardiac tissue repair).Manufacturing review of the proxicor (cormatrix ecm) for cardiac tissue repair device history record(s) could not be completed as the lot/serial numbers(s) were not provided.No product was returned to aziyo biologics for investigation.It is noted that per the aziyo instructions for use (ifu-art-20700b) provided with the finished ctr device (as well as ifu for same product manufactured previously by cormatrix during the dates related to this patient study), stenosis is listed as a potential complication associated with the procedure and device.Although the exact cause of the reported stenosis cannot be conclusively determined, stenosis is a known complication associated with the use of the ctr device in a surgical implant procedure.No additional information is available regarding the reported event(s), should any additional information be received, a follow-up report will be submitted.

Event Description

As part of the post market surveillance process, this retrospective review of procedures conducted between oct.2011 and apr.2016 for a single center, two physician study was published in frontiers in pediatrics (30may2018, vol 6, article 149) titled "is decellularized porcine small intestine submucosa patch suitable for aortic arch repair?" was reviewed.The study consisted of 51 patients with a variety of congenital cardiac defects who underwent various repairs including an aortic arch repair with a dpsis (decellularized porcine small intestinal submucosa) patch for aortic enlargement.While the device was not specifically identified, it was likely the cormatrix ecm (now aziyo proxicor) for cardiac tissue repair based upon a review of aziyo ecm products and their respective indications for use.The study focused on the results of the aortic arch repair and not other concomitant surgeries.It was reported that 13/51 patients (25.5%) who had the patch surgically implanted required reintervention for obstruction of the repair.The mean interval between patch implantation and reintervention was 6 months (10 days-17 months).Article also reported "no early or late mortality occurred for the dpsis patch surgical implantation and also for the subsequent interventional procedure or surgery." the median age for the patient group (51 patients) was 1.1 months (range 5 days to 14.5 years) and median weight was 4.0kg (range 2.2 - 50.2kg).The article provides table 1 summarizing the 13 patients requiring re-intervention, by their initial diagnosis, associated lesions, initial operation, and re-intervention.No other details are provided regarding the specific patients, or products used, and associated lot numbers.Therefore summarized adverse events within this article have been grouped where possible by initial diagnosis, initial operation and re-intervention and reported within eight (8) individual mdr reports.This specific mdr is associated with patients #1, #2, and #12 as listed in table 1.These patients underwent an aortic arch patch enlargement for hypoplastic aortic arch, and closure of a ventricular septal defect repair.Re-interventions were required for stenosis.One (1) event surgical, another for balloon dilation, and the remaining event is a planned re-intervention.Follow-up contact with the corresponding author did not provide any further details regarding specific product used and corresponding lot numbers.A summary excel spreadsheet has been attached for specific patient codes associated with each of the three (3) reported interventions associated with this report.

• Brand Name: PROXICOR 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: 11712795
• MDR Text Key: 263438244
• Report Number: 3005619880-2021-00007
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/22/2021

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: 03/24/2021
• Initial Date FDA Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention