MAUDE Adverse Event Report: AZIYO BIOLOGICS, INC. TYKE; PATCH, PLEDGET-INTRACARDIAC-DXZ

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

Patient Problems Aneurysm (1708); Stenosis (2263); Pseudoaneurysm (2605)

Event Date 06/28/2021

Event Type  Injury  

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 5 patients in the tyke 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 2 of the tyke patients.The third stenosis event occurred in a patient who had a right atrium-superior vena cava connection created.It is noted that per the instructions for use (ifu - art-20712a) provided with the finished tyke device for the time period of this study, that certain warnings and precautions are included.The ifu states, "tyke should only be used to reconstruct curved structures less than or equal to 12mm in diameter." it further states that "tyke should only be used to reconstruct structures where the post-operative pressures is not expected to exceed 50 mmhg." it is unknown if the repairs made using this device experienced these conditions.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.

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 tyke product (model # / lot # - unknown) and a previous mdr was submitted for the second aziyo product, proxicor for cardiac tissue repair.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 5.35 kg.The tyke product was used as follows: patients with arterioplasty-21, patients with venoplasty-6, patients with intracardiac repair-4, patients with intracardiac valve repair-1.The adverse events for this cohort that required reintervention were: pseudoaneurysm, aneurysm, stenosis events.There were no deaths reported related to the tyke ecm patch.

• Brand Name: TYKE
• 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: 13110940
• MDR Text Key: 288290955
• Report Number: 3005619880-2021-00048
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152127
• 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: 12/28/2021

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