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

Model Number UNKNOWN

Device Problem Off-Label Use (1494)

Patient Problem Pulmonary Valve Insufficiency/ Regurgitation (4452)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

No sample was returned for evaluation.Manufacturing review of the proxicor for cardiac tissue repair device history record could not be completed as no model or lot numbers were reported.The instructions for use (ifu-art-20700a) provided with the finished proxicor ctr device lists the indications for use as an "intracardiac patch or pledget of tissue repair (i.E.Atrial septal defect, ventricular septal defect, etc.) and suture-line buttressing." it further instructs that the edge of the proxicor device must be in contact with viable tissue.Per the "indication for cormatrix patch use" delineated in table 1 of the publication, the proxicor product was used to create a valve.This is an off-label application of this product.It neither follows the "indications for use" of this product nor allows for all edges of the device to be in contact with viable tissue as recommended.The ifu further lists "stenosis," "calcification, " "acute or chronic inflammation," and "undesired remodeling (including poor tissue integration, excessive scar tissue formation)" as potential complications associated with use of the proxicor for cardiac tissue repair device.The authors expressed that the histology reports of the explanted devices did not demonstrate expected resorption of the aziyo proxicor for cardiac tissue repair (extracellular matrix) material but instead showed chronic inflammatory reactions, leading to calcification.It is noted that the valve created out of the ecm tissue would not have had all sides sewn to viable tissue, as instructed in the ifu.This could have impacted the ability of the tissue to act as a scaffold and to attract the needed processes for remodeling.Blood flow to the valve would have only existed on the single surface where the ecm abutted viable tissue.

Event Description

Post market surveillance review of publication entitled, "histological analysis of failed submucosa patches in congenital cardiac surgery" (asian cardiovasc thorac ann.2019 jul;27(6):459-463) was reviewed and summarized as follows: this was a retrospective study involving 4 patients (9 months to 41 years of age), who underwent reoperation due to early patch failure (failure between 69 to 553 days).Explanted patch material from the 4 patients was sent for histopathological evaluation.This mdr will cover patient #1 listed in table 1 of the article.Subsequent mdrs will be filed for the other three cases.While the focus of the publication was on the histological findings post-explant, the need for reintervention and explantation will be described in this report.Patient #1 underwent "neo-prosthesis of the pulmonary valve." the patient experienced the failure mode of "insufficiency of the pulmonary valve" and had the valve explanted at 553 days post-op.

• Brand Name: PROXICOR FOR CARDIAC TISSUE REPAIR
• Type of Device: PATCH, PLEDGET
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• MDR Report Key: 12676136
• MDR Text Key: 284308396
• Report Number: 3005619880-2021-00036
• 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: foreign,literature
• Type of Report: Initial
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR