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

Model Number CMCV-120-404

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Injury  

Manufacturer Narrative

Manufacturing review of the cormatrix ecm for cardiac tissue repair (now aziyo proxicor for cardiac tissue repair) device history record could not be completed as the lot/serial number was not provided.It is also noted that per the instructions for use (ifu - art-20700b) provided with the finished proxicor for cardiac tissue repair device, localized inflammation, patch dehiscence or rupture, or reformation of cardiac defect are listed as a potential complications associated with the procedure and device.In addition, the ifu for the proxicor for cardiac tissue repair device provides a warning/precaution that the device must be sutured to viable native tissue.Indicating that all edges of sutured ecm patch be made to viable tissue which would exclude leaving a "free-edge" to simulate the commissural closure of the valve cusps.Further, the ifu states under suggested instructions for implanting proxicor for cardiac tissue repair to "place the edge of the proxicor in contact with viable tissue." although the exact cause of the reported aortic insufficiency issue cannot be conclusively determined, localized inflammation, patch dehiscence or rupture, reformation of cardiac defect, are known complications associated with the use of a proxicor for cardiac tissue repair and this surgical implant procedure.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 article / clinical case report published in xenotransplantation 2017;24:e12341 titled "congenital aortic valve repair using cormatrix: a histologic evaluation" was reviewed.This article reports a retrospective review of six (6) patients who underwent surgery for severe aortic valve stenosis (4 patients) or regurgitation (2 patients) between april and july 2013.Aortic valve repair was performed on all patients using decm cormatrix as a leaflet replacement or extension.This report is focused on patient #4 (per publication table 1: demographic and surgical details) where a (b)(6) yr.Old male with aortic insufficiency (grade 3) underwent a replacement of the right cusp, augmentation of the anterior cusp and left cusp shaving procedure using cormatrix (now aziyo biologics) decm (model #: unknown [likely to be proxicor for cardiac tissue repair], lot #: unknown) with the new cusp in contact to the aortic wall.Following operation patient demonstrated satisfactory results with grade 1 insufficiency and good mobility of the tissue observed at 1mo.At the 3 month follow-up, patient presented with grade 3 aortic insufficiency and reoperation performed on post-op day 122.Attempts to contact corresponding author have been unsuccessful for any additional information.Should any additional information be received a follow-up report will be filed.

• Brand Name: PROXICOR 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: 10680461
• MDR Text Key: 211492294
• Report Number: 3005619880-2020-00052
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K063349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CMCV-120-404
• 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: 12 YR