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

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

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

Manufacturing review of the cormatrix ecm for cardiac tissue repair device history record(s) could not be completed as the lot/serial number(s) were not provided.It is noted that the reported complication of re-intubation and potential for tracheostomy for respiratory difficulties are likely complications associated with the procedure and not of the surgical repair of the heart itself.No further details were provided in the published literature relating to these events and attempts to contact corresponding author have been unsucessful at the time of this report.Should aziyo receive any additional details related to these events, a supplemental report will be filed.

Event Description

As part of the post market surveillance process, this single center retrospective clinical review published in congenital heart disease titled "complete atrioventricular canal repair with a decellularized porcine small intestinal submucosa patch" was reviewed.This article summarizes the results of seventy-three (73) pediatric patients treated for complete atrioventricular canal repair using either a two-patch technique with cormatrix ecm for cardiac tissue repair or a modified single-patch "(b)(4)" repair.For the two-patch technique, the cormatrix ecm for cardiac tissue repair was used primarily for ventricular septal defect repair (vsd) while autologous pericardium was used for atrial septal defect (asd) repair.For the modified single-patch technique, cormatrix ecm for cardiac tissue repair was used in 15 of 21 cases.Fifty-two (52) patients were treated using the two-patch repair while another twenty-one (21) patients were treated with the modified australian repair.Of these patients, the article states that that a total of thirteen (13) re-intubations were required with four (4) of these re-intubations leading to a tracheostomy.This retrospective review evaluated patient procedures conducted between 3/2010 and 9/2017.The article provides no additional details relating to the events leading to the re-intubation, or the tracheostomies performed.The article provided no details as to treatment technique used for these patients and whether only cormatrix ecm for cardiac tissue repair, autologous pericardium, or combination of both products were used in each respective procedure.Attempts to contact the corresponding author have been unsuccessful at time of this report regarding specific product used and corresponding lot numbers.Should any additional information be received a follow-up report will be filed.

Manufacturer Narrative

Aziyo biologics would like to amend/correct the following data fields of this mdr report per notification from fda mdr team of incorrect usage of box h.1 - summary report and corresponding no.Of events summarized: fields to be corrected (from/to): box b.3 --- from: blank (no date provided) ------> to: 11/01/2018 (only month/year provided) reason: lack of specific publication date resulted in decision not to "estimate".Box g.2 --- from: foreign, study, and literature selected -------> to: literature (only selected) reason: aziyo became aware of the foreign study via the published literature only.Box h.5 ----from: article summary (keep as is) -------> to: article summary amended to add that this mdr is one (1) of four (4) mdrs submitted for this published literature.This mdr summarizes the events surrounding thirteen (13) reported post-operative re-intubations with four (4) of those re-intubations requiring a tracheostomy.Summary data regarding the73 patients in this restrospective review had an average age of 22 weeks +/- 23 weeks (range from 2.5 weeks to 184.4 weeks).A total of 82% of patients had trisomy 21, 3% had previous pulmonary artery banding.Females represented the majority of patients (54.8%), with an average weight of 5.0 kg+/- 1.5 kg.Cormatrix ecm was used in 56 patients (76.7%) for ventricular septal defect repair and 55 patients for repair of atrial septal defects.Reason: additional summary information requested per mdr reporting guidance document section 4.16.2 box h.1 --- from: selection of serious injury and summary report with 13 events summarized ----> to: serious injury selected only (de-select summary report and no.Events summarized) reason: notification from fda mdr team of improper use of summary report box - submission not intended to be reported via vmsr program box h.6 --- from: health effect - clinical code: 4464 ------> to: remove code box h.6 --- from: health effect - impact code: 4607, 4641, 4620 ------> to: remove all codes box h.6 --- from: medical device problem code: 2993 ------> to: remove code box h.6 --- from: component code: 4755 ------> to: remove code box h.6 --- from: type of investigation: 4117 ------> to: remove code box h.6 --- from: investigation findings: 3221 ------> to: remove code box h.6 --- from: investigation conclusions: 4315 ------> to: remove code reason: per medical device reporting for manfacturers guidance for industry, section 4.16 - reports based on literature, specifically section 4.16.2 (bullet point #4 - pg.36) an excel spreadsheet is provided as an attached document providing all reporting codes for each summarized event (post-operative re-intubation (13 events - 4 of which resulting in tracheostomies).

• Brand Name: CORMATRIX ECM 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
• MDR Report Key: 11091636
• MDR Text Key: 230779039
• Report Number: 3005619880-2020-00086
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• PMA/PMN Number: K063349
• Number of Events Reported: 13
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: literature,study
• Type of Report: Initial,Followup
• Report Date: 04/05/2021

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
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 11/08/2018
• Supplement Dates FDA Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention