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

Model Number CMCV-120-401

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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-20700) provided with the finished proxicor for cardiac tissue repair device that the intended use/indications for use for this products is for use as an intracardiac patch or pledget for tissue repair [i.E., atrial septal defect (asd), ventricular septal defect (vsd), etc.] and suture-line buttressing.Although the exact cause of the reported event for paravalvular leakage cannot be conclusively determined, paravalvular leakage is a known complication associated with a valve replacement surgical procedure.No further details are available at this time, 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 interactive cardiovascular thoracic surgery titled "combined total mitral and tricuspid valve reconstruction with the use of cormatrix in an adult" was reviewed.The article summarizes the usage of two pieces of cormatrix ecm to form both a mitral valve (7cm x 10cm) and tricuspid valve (7cm x 15cm) prosthesis with additional subvalvular apparatus attached to the three papillary muscles.Due to material size 7cm x 15cm, it can be confirmed that one product was the cormatrix ecm for pericardial closure (model # cmcv-118-402; lot #: unknown), however, as the reported event occurred in the mitral valve location, this product is not implicated in the event.The second material size utilized to form the mitral prosthesis is offered in both the cardiac tissue repair and pericardial closure product lines.This report is focused on the usage of the 7cm x 10cm piece of ecm used to form the mitral valve and is likely to have been cormatrix ecm for cardiac tissue repair (model # cmcv-120-401; lot #: unknown).The case report references a (b)(6) yr-old male patient with history of acromegaly, ectasia of atrioventricular annuluses and macrocardia with significant mitral and tricuspid regurgitation.On post-operative day 4, a transthoracic echocardiogram (tte) showed both valves functioning properly and the cardiac cavities were alleviated considerably.On post-operative day 11 a tte showed a paravalvular leak on the mitral prosthesis approximately 6 millimeters in diameter.On post-operative day 31, the patient underwent re-operation and the fistula was closed and the remaining post-operative period was uneventful.Follow-up transthoracic echocardiogram 8 days post-repair showed no paravalvular leak, and tissue culture samples from the repair procedure showed no micro-organisms.Patient was released on post-operative day 52 in good condition.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.

• 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
• MDR Report Key: 11078432
• MDR Text Key: 223814457
• Report Number: 3005619880-2020-00080
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K063349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CMCV-120-401
• 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): Required Intervention
• Patient Age: 43 YR