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

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

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 09/26/2020

Event Type  Injury  

Manufacturer Narrative

No sample was returned for investigation.Manufacturing review of the device history record could not be completed as the model number/lot number were not provided.It is noted that in the instructions for use (art-20706a) provided with the proxicor for cardiac tissue repair, it states under the warnings and precautions section that "device must be sutured to viable native tissue." ventricular septal defect noted to be "ischemic" by authors, so patch likely difficult to attach to viable tissue.The same ifu also lists "aneurysm," "patch dehiscence or rupture," "reformation of intracardiac defect," and "undesired remodeling, including rapid degradation" as potential complications associated with the use of this device.No additional information is expected as implanting physician is no longer practicing at this hospital.

Event Description

During post market surveillance, an article entitled "recurrent ventricular septal defect following closure cormatrix: a case report," journal of cardiology surgery, 2021 jan;36(1):392-395 was reviewed and summarized as follows: this was a case study of a (b)(6) female with ventricular septal rupture and posterior left ventricular aneurysm following late presentation after a myocardial infarction that required operative repair.Coronary artery bypass and repair of posterior left ventricular (lv) aneurysm was performed with a cormatrix (now aziyo biologics) ecm patch.Although the referenced material is reported as a cormatrix patch, this is likely the aziyo proxicor for cardiac tissue repair product (model # & lot #: unknown).Approximately seven (7) months later, patient was readmitted to hospital for dyspnea and poor exercise tolerance and diagnosed with a recurrent ventricular septal defect (vsd), dehiscence of vsd repair patch, and inferior/posterior aneurysm.She underwent a vsd repair revision and aneurysm repair with a gelweave patch and tricuspid valve repair.During surgery, the cormatrix patch was found to be almost completely disintegrated and reabsorbed with the suture lines intact.Attempts to obtain further details were unsuccessful as the author stated that the surgeon performing the initial procedure was no longer working at this hospital.Should any additional information be received related to this event, a follow-up report will be filed.

• Brand Name: PROXICOR FOR CARDIAC TISSUE REPAIR
• Type of Device: PATCH, PLEDGET AND 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: 12133850
• MDR Text Key: 260440175
• Report Number: 3005619880-2021-00022
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2021
• 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
• Patient Age: 58 YR