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 Problems Arrhythmia (1721); Bradycardia (1751); Pneumonia (2011); Sepsis (2067); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 09/11/2017

Event Type  Death  

Manufacturer Narrative

Manufacturing review of the cormatrix ecm for cardiac tissue repair device history record could not be completed as the lot/serial number was not provided.It is noted that per the instructions for use (ifu - art-20706) provided with the finished cormatrix ecm for cardiac tissue repair device, infection, bleeding are listed as a potential complications associated with the procedure and device.Although the exact causes of the reported deaths cannot be conclusively determined, infection, bleeding are known complications associated with the use of a cormatrix ecm for cardiac tissue repair and a surgical implant procedures and are identified in the instructions for use as potential complications provided with the proxicor (cormatrix ecm) for cardiac tissue repair.Should aziyo receive any additional details related to this event, a supplemental report will be filed.

Event Description

As part of the post market surveillance process, this retrospective single center study report(s) published in kardiologia polska titled "early results of aortic arch reconstruction and bilateral pulmonary artery banding: modification of the norwood operation for treatment of hypoplastic left heart syndrome" (article 1) and in cardiovascular ultrasound titled: "preoperative single ventricle function determines early outcome after second-stage palliation of single ventricle heart" (article 2) were reviewed.A total of ninety-six (96) norwood 1 procedures were reviewed during these study periods consisting of group i included 59 children whom the stage i norwood procedure with the sano modification was performed with a homogenous pulmonary artery or a bovine pericardial patch.Group ii (article 1) and group bdg (article 2) included 37 children after modification of the norwood i procedure, in which the aortic arch was reconstructed with an extracellular matrix patch and bilateral pulmonary artery banding was done.Patients were treated between 2003 and december 2015 (article 1), or 2011 through end of 2015 (article 2) respectively, using the cormatrix (now aziyo biologics) extracellular matrix material (model # / lot #: unknown), but likely cormatrix ecm for cardiac tissue repair (now proxicor for cardiac tissue repair).The first data of the long-term results was published as pajak j, et al.Cardiovasc ultrasound.2017 sep 11;15(1):21.(article 2).Additional data was published as pajak j, et al.Kardiol pol.2018;76(4):770-775.(article 1).Only group ii utilized aziyo extracellular matrix will be included in this report.This report will address the six (6) deaths summarized within table 1 where a 30-day hospital mortality rate of 16.2% (6) was stated; due to bleeding (1), pneumonia/sepsis (1) and low cardiac output (4).Article 2 provides additional detail into the 4 patients with low cardiac output as slow sinus rhythm (1), sinus bradycardia (1) and tachyarrhythmia with reaction to pharmacotherapy (2).Additional details of the 6 deaths include: 2 of the 6 patients had preoperative pneumonia/sepsis and all 6 patients had their chest left open postoperatively (refer to table 3 from article 1).It can be noted that all 37 children had atrioventricular valve regurgitation (avvr) and/or single ventricle heart function of varying degrees as seen both preoperatively and postoperatively (refer to table 2 from article 2).Follow-up attempts to contact the corresponding author have been unsuccessful and no details have been provided 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: 09/11/2017.Reason: oversight due to same patient population summarized in 2 different articles, earliest publication date selected.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 three (3) mdrs submitted for this published literature.This mdr summarizes the events surrounding six (6) patient deaths.Summary data regarding patients in article 1 with initial norwood 1 procedure to the following: mean body mass on day of operation was 3.32 kg +/- 0.7 kg.Mean age at operation was 17 days (range 0 to 87 days).Study group of 96 patients comprised of 34 (29.7%) female and 62 (70.2%) male - no specific breakdown in respective treatment groups.Article 2 patient group with 2nd stage palliation with hemi-fontan or bi-directional glenn procedure to the following: mean body mass on day of operation was 6.7 kg +/- 1.2 kg.Mean age at operation was 33 weeks +/- 11.2 weeks.Bdg study group of 37 patients comprised of 15 (40.5%) had direct end to end anastomosis between superior vena cava (svc) and right pulmonary artery.Remaining 22 patients had svc and right pulmonary artery anastomosis extended by use of ecm patch.Reason: additional summary information requested per mdr reporting guidance document section 4.16.2.Box h.1 : from: selection of death and summary report with 6 events summarized : to: death 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: 1751, 1721, 2067, 2011, 4450.: to: remove all codes.Box h.6 : from: health effect - impact code: 1802, 4644.: 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: 4114.: 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 (deaths - 6 occurrences).

• 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: 11060416
• MDR Text Key: 223357418
• Report Number: 3005619880-2020-00077
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• PMA/PMN Number: K063349
• Number of Events Reported: 6
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: foreign,literature,study
• Type of Report: Initial,Followup
• Report Date: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• 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: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death