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

Device Problems Off-Label Use (1494); Loosening of Implant Not Related to Bone-Ingrowth (4002); Separation Problem (4043)

Patient Problem Failure to Anastomose (1028)

Event Date 01/05/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturing review of the proxicor (cormatrix ecm) for cardiac tissue repair device history record(s) could not be completed as the lot/serial number(s) were not provided.It is noted that the instructions for use in use at the time of article publication (art-20553) did not include a warning / precaution about not using proxicor for cardiac tissue repair for the construction or replacement of total valves or conduits, which has since been implemented in 2018 labeling.However, it should be noted that the indications for use for the proxicor (cormatrix ecm) for cardiac tissue repair has not changed since the initial 510k approval and remains as "the proxicor (cormatrix ecm) for cardiac tissue repair is indicated for use as an intracardiac patch or pledget for tissue repair [i.E., atrial septal defect (asd), and ventricular septal defect (vsd), etc.] and suture-line buttressing".This product is not indicated for valve replacement.No further details were provided in the published literature regarding product used, or manufacturing lot number.Should any additional information be received following attempts to contact corresponding author, a supplemental report will be filed.

Event Description

As part of the post market surveillance process, this single center case study published in the interactive cardiovascular and thoracic surgery 24 (2017) 639-640, doc 10.1093/icts/ivw406 (advance access publication 5jan2017) titled "mitral valve replacement using a handmade construct in an infant", was reviewed.This article summarizes the results of an aziyo biologics 4-ply extracellular matrix product (model #: unknown; lot # unknown) likely to be proxicor for cardiac tissue repair on an unknown date.The surgeon used the proxicor for cardiac tissue repair off-label to fashion a 12mm mitral valve to replace a congenitally un-repairable defective valve in a 4-month old infant.Following placement, confirmation of valve competency was demonstrated via echocardiogram and followed by closure.At 24-hours post-operation, an echocardiogram demonstrated neo mitral valve dehiscence at the papillary muscle attachment to ventricle.The patient was taken back to surgery where friable tissue was identified at the previous papillary muscle attachment of the ecm valve.Pledgets were used to anchor the valve transmurally to the ventricular muscle.Intra-operative echocardiogram revealed no mitral insufficiency and no inflow stenosis, patient was decannulated from extracorporeal membrane oxygenation 4 days later.Valve continued to function without issue for 8.5 months following repair prior to patient expiring due to pulmonary complications (pneumothorax and intrapulmonary hemorrhage) likely related to the fibrillin gene defect, which was confirmed via genetic testing.No additional information is available following attempt to contact corresponding author.Should any addiitonal information be received relative to aziyo product used, lot number, etc., a supplemental filing will be submitted.

• 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
• MDR Report Key: 11599752
• MDR Text Key: 260935319
• Report Number: 3005619880-2021-00016
• 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: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2021
• Initial Date FDA Received: 03/31/2021
• 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: 4 MO