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

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Unspecified Infection (1930)

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.Information cited in the article states that ".Ecm patch material is expensive and the availability may be limited.We have used this material in our patient population by carefully cutting the new patch, as supplied, into 10 equal pieces at the time of the first use, and then resterilizing the remaining pieces for use in subsequent patient.During our re-sterilization procedure, we took precautions to sterilize it properly and adequately.We did not notice any infections that we believed could be attributed to this cost saving strategy." although the exact cause of the reported issues cannot be conclusively determined, this event infection (systemic) which ultimately resulted in a patient death is identified in the instructions for use provided with the proxicor (cormatrix ecm) for cardiac tissue repair.Further the provided instructions for use (art-20706a) state under warnings and precautions that "for single patient use only.Do not reuse, reprocess or resterilize.Reuse, reprocessing or resterilization will compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death".Individual device pouch, display envelope or carton labels display the fda/iso compliant symbols for do not reuse and do not resterilize.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 published in the world journal of pediatric and congenital heart surgery titled "preliminary experience with the use of an extracellular matrix to augment the native pulmonary valve during repair of tetrology of fallot" was reviewed.This article summarizes the results of fifty-two (52) patients who underwent surgery for right ventricular outflow tract (rvot) reconstruction and pulmonary valve augmentation during tetrology of fallot requiring a transannular incision.Patients were treated between march 2013 and december 2015 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).This report is focused patient #2 of 2 patients experiencing systemic infections in the late postoperative period unrelated to the use of the cormatrix patch material and died.The patient was operated on emergency basis while on mechanical ventilator support because of cyanotic spells and developed low cardiac output in the setting of lung infections.Blood cultures were negative and no evidence of infection related to the use of the ecm patch material.The valve demonstrated good function without significant regurgitation.Attempts to contact the corresponding author have been provided minimal additional information regarding specific product used and corresponding lot numbers.Should any additional information be received a follow-up report will be filed.

• 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
• 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 ; 4705144023
• MDR Report Key: 10865279
• MDR Text Key: 217067200
• Report Number: 3005619880-2020-00071
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K063349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2018
• 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): Death