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

Device Problem Material Puncture/Hole (1504)

Patient Problems Stenosis (2263); Pseudoaneurysm (2605)

Event Date 06/28/2021

Event Type  Injury  

Event Description

As part of the post market surveillance process, this single center retrospective clinical review published in the annals for thoracic surgery entitled "over 400 uses of an intestinal submucosal extracellular matrix patch in a congenital heart program" was reviewed.This article summarizes the results of a review of three hundred nine (309) patients who received a total of four hundred eight (408) patches during the repair of congenital heart defects.The chart review covered two aziyo products--this report is for the proxicor for cardiac tissue repair product (model # / lot # unknown) and a subsequent mdr will report the second aziyo product, tyke.The study reviewed patient records from 2012-2019 and used as its endpoint the need for unplanned reintervention during follow-up vs.Freedom from reintervention.The median age of the study participants was 8.5 months.Overall median follow-up time was 3.9 years (range 3 days-7.4 years).60% were male and 74% were white.Median weight for this cohort was 8.7kg.The proxicor for cardiac tissue repair product was used as follows: patients with arterioplasty-293.Patients with venoplasty-16.Patients with intracardiac repair-59.Patients with intracardiac valve repair-8.The adverse events for this cohort that required reintervention were: 5 pseudoaneurysms.2 malfunctions of the ecm patch (1 hole, 1 delamination).25 stenosis events.There were no deaths reported related to the proxicor ecm patch.

Manufacturer Narrative

No product was returned for evaluation.Manufacturing review of the device history record for this complaint could not be performed as the specific model number and the lot number of the device was not provided.There was no apparent off-label usage of the product cited in this article.However, additional information received from one of the authors detailed some off-label usages included in each cohort but none of those uses were correlated with the reported adverse events at follow-up so are not included in this investigation.The publication identified 32 patients in the proxicor cohort who required reintervention.The authors commented on the patients who required reoperation for pseudoaneurysms, stating that "almost all of these patients had small pas [pulmonary arteries] that we were attempting to grow" and stated that they were unsure if this was an issue with the patch itself or was due to technical issues related to the surgery itself, as they had seen this with other types of patches.Regarding the stenosis events, the authors noted that three-quarters of the patients in the study who required reintervention for stenosis were pulmonary artery patients.This included 18 of the proxicor patients.Two other stenosis events were reported for the superior vena cava requiring reintervention.The reported "hole" was in a long patch used to baffle a ventricular septal defect to an anteriorly translocated aorta by creating a intraventricular tunnel--no further details regarding the failure were provided.The delamination occurred in a patch used to reconstruct the right ventricular outflow tract.It is noted that per the instructions for use (ifu - art-20706a) provided with the finished proxicor for cardiac tissue repair device for the time period of this study, stenosis, pseudoaneurysm, patch rupture and degradation of the product are listed as potential complications associated with the use of the device.The exact cause of the reported events cannot be conclusively determined and no histology was reported.The patients in this study were all undergoing complex surgeries, requiring reconstruction of miniscule cardiac structures and then adding the likelihood of growth of the child/structure which would add more complexity to the areas where the product was used.The authors point out that they have refined their techniques in the use of this product as well as restricting it to particular applications for which it appears best suited.

• 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: 13110522
• MDR Text Key: 288322971
• Report Number: 3005619880-2021-00047
• 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: Study,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• 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: 12/01/2021
• 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