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

Model Number CMCV-120-401

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Aortic Valve Stenosis (1717); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Injury  

Manufacturer Narrative

Manufacturing review of the proxicor for cardiac tissue repair device history record could not be performed.The lot/serial number is unknown.It is also noted that per the instructions for use (ifu - art-20700b) provided with the finished proxicor for cardiac tissue repair device, stenosis, patch dehiscence/rupture are listed as 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, in the suggested instructions for use (e.G.Implant) it is stated "7.Place the edge of proxicor in contact with viable tissue".Although the exact cause of the reported stenosis and patch prolapse (dehiscence/rupture) cannot be conclusively determined, these are known complications associated with the use of a proxicor for cardiac tissue repair and a 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 annals of thoracic surgery 2017;104:e431-3 titled "calcific degeneration of cormatrix 4 years after bicuspidization of unicuspid aortic valve" was reviewed.This article reports a case study related to a 12 year old boy with congenital aortic valve (av) stenosis treated with balloon valvuloplasty in infancy which had progressed to severe av stenosis.The patient underwent a bicuspidization procedure of a severely stenotic unicuspid aortic valve with cormatrix (now aziyo biologics) ecm for cardiac tissue repair (model #: cmcv-120-401, lot #: unknown) which upon completion of procedure demonstrated acceptable surgical and echocardiographic results.Patient evaluated every 3 months (1st year) and 6 months thereafter (2nd year) showing a stable and well-functioning aortic valve without any changes in leaflet size, integrity, function, or progression of postoperative mild insufficiency.At 52.5 months patient presented with progressive dyspnea.Echocardiography showed patch prolapse with severe aortic regurgitation, mild stenosis, and left ventricular dilatation.Reintervention was indicated, and the patient underwent a ross procedure.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 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 30076 ; 4705144023
• MDR Report Key: 10673565
• MDR Text Key: 211335207
• Report Number: 3005619880-2020-00048
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• 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: 14 YR