MAUDE Adverse Event Report: AZIYO BIOLOGICS, INC. PROXICOR FOR CARDIAC TISSUE REPAIR; MESH, SURGICAL-FTM

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

Patient Problems Stenosis (2263); Restenosis (4576)

Event Date 06/04/2016

Event Type  Injury  

Manufacturer Narrative

No information was received providing the manufacturing model or lot number 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).The specific cause of stenosis was not detailed in the article.There was no elaboration on complications that led to reinterventions and if the ecm patch was associated with any complications.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 pulmonary artery patch repair and is listed on the instructions for use (art-20706) distributed with proxicor for cardiac tissue repair (cormatrix ecm 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 these publications.Should any additional information be received, a follow-up report will be submitted.Attached spreadsheet shows 14 events of reintervention for recurrent stenosis for this product.

Event Description

During post market surveillance, the following publications were reviewed and summarized: poster #1418 (entitled "comparison of outcomes after extracellular matrix patch and standard patch augmentation of pulmonary arteries in pediatric congenital heart disease") and corresponding publication #1419 (entitled "comparison of extracellular matrix patch and standard patch material in the pulmonary arteries").Studies were on the same set of retrospective data generated in the us from jan.2004 - dec.2013 for pulmonary artery patch repair.Summary as follows: 221 pts included, 48 with cormatrix ecm (extracellular matrix) and 173 with standard patch (sp).29% of ecm group (14 patients ) and 39% (67 patient) of sp group underwent reintervention with median time to reintervention for all patients 1099 days.This study showed equivalent timing to reintervention between the two study groups.No difference in reintervention-free survival rates between the patch groups.In the article, "reintervention" is defined as "any surgery or cardiac catheterization that took place after the initial pa (pulmonary artery) surgery intended to relieve residual or recurrent pa stenosis.Therefore, the 14 ecm patient requiring re-intervention are categorized as "stenosis/recurrent stenosis" for reporting.A spreadsheet for these 14 events is attached summarizing the 14 events.No information was provided in the article specifying the particular product or model numbers used in these procedures, nor the manufacturing lot numbers.Follow-up attempts to contact the corresponding authors have been unsuccessful and no further details have been provided regarding specific product used and corresponding lot numbers.Cormatrix ecm is referenced as the patch used which, based on the indications for use, is now branded as the aziyo product proxicor for cardiac tissue repair.Should any additional details be received regarding these events, a follow-up report will be filed.

Manufacturer Narrative

Corrected fda type of device - device product code information in d2 to dxz.Field inadvertently populated with another aziyo biologics product information (ftm) at initial report filing.Issue identified during maude database review.

• Brand Name: PROXICOR FOR CARDIAC TISSUE REPAIR
• Type of Device: MESH, SURGICAL-FTM
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• MDR Report Key: 11706298
• MDR Text Key: 246690366
• Report Number: 3005619880-2021-00006
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• PMA/PMN Number: K063349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

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
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention