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); Restenosis (4576)

Event Date 10/08/2020

Event Type  Injury  

Manufacturer Narrative

No information was received providing the manufacturing models involved with these procedures.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 were not provided.The specific cause of reported stenosis was not detailed in the article.There was no elaboration on complications that led to reinterventions other than "haemodynamically relevant stenosis following surgery." no histology was reported and no further details supplied by the researchers.While no alleged product deficiency, quality or performance issue, dissatisfaction etc.Was made about the cormatrix ecm, stenosis is a known complication associated with surgical procedures including septal defect repair and arterial vessel repair and is referenced as a potential complication in the instructions for use (art-20700b) distributed with aziyo (cormatrix ecm) proxicor for cardiac tissue repair device.No product was returned to aziyo biologics for investigation and no further information was received in response to our attempts to contact the corresponding author of this presentation.Should any additional information be received, a follow-up report will be submitted.Attached is a spreadsheet reflecting the 12 reported events for stenosis.

Event Description

Per post market surveillance, review of data provided during a presentation at the 2020 european association for cardio-thoracic surgery (eacts) id#(b)(4) (october 8-10, 2020) entitled "cormatrix for vessel reconstruction in pediatric cardiac surgery--a word of caution," was reviewed and summarized as follows: this retrospective study of 57 consecutive patients with various cardiac defects (28 with septal defects, 21 with arterial vessel reconstruction, 4 with valve reconstruction and 4 with venous vessel/atrial reconstruction ("other")) repaired with cormatrix ecm patches were compared with 36 patients treated with autologous pericardial patches.Authors observed that the ecm patch implanted to repair septal defects performed well while ecm patches implanted to repair arterial vessels was "riskier" and resulted in significantly more stenosis compared with the autologous pericardium cohort.Authors reported 12 re-intervention procedures for stenosis/recurrent stenosis related to ecm in the total patient population who received cormatrix.Of the 57 patients who had ecm: 8 with arterial plasty with ecm required reintervention for stenosis.2 who had valve repair with ecm required valve repair reintervention for stenosis.2 "other" (venous vessel plasty or atrial reconstruction) with ecm required reintervention for stenosis.(18 had reinterventions unrelated to the ecm surgery).The article fails to delineate specific details related to the 12 patients requiring some level of intervention, so this report is being filed summarizing the 12 reported events for stenosis/recurrent stenosis.Attached is a spreadsheet with the associated reporting codes fordetails of each group requiring re-intervention and all codes related to these events, which are the same codes throughout.No specific product related details such as model/reorder numbers or manufacturing lot numbers were provided in these presentation slides.As such, based on associated indications for use for aziyo products, the product is likely to be the aziyo proxicor for cardiac tissue repair.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: 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: 11706299
• MDR Text Key: 262975393
• Report Number: 3005619880-2021-00015
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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

• Date FDA Received: 04/22/2021
• 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: 03/24/2021
• 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