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

Device Problem Incomplete Coaptation (2507)

Patient Problem Valvular Insufficiency/ Regurgitation (4449)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

No sample was returned for investigation therefore no manufacturing records could be reviewed as part of aziyo's investigation.While the specific product was not referenced in the article, the authors did make reference to a "large cormatrix patch", which could potentially be the proxicor for cardiac tissue repair, with 7cm x 10cm being the largest size.The instructions for use provided with the proxicor for cardiac tissue repair (art-20700b) lists the indications for use as follows: "proxicor¿ for cardiac tissue repair is indicated 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." the patch is required to be sutured to viable tissue on all sides.Use of this product to augment valve leaflets is considered to be an off-label use of this product.

Event Description

During post market surveillance, an article entitled (b)(6) heart surg forum, 2021 mar 8;24(2): e261-e266 was reviewed and summarized as follows: retrospective analysis of 424 patients undergoing tricuspid valve procedures between 1/2013 and 8/2018: 420 anterior leaflet patch augmentation/repairs & 4 tricuspid valve replacements.Out of the valve repairs cohort, 19 patients had cormatrix (currently aziyo biologics) ecm patches, likely proxicor for cardiac tissue repair - (model# / lot#: unknown) used for anterior leaflet augmentation of tricuspid valve - 5 patients having isolated repair - augmentation only & 14 repairs conducted with concomitant surgeries on another valve.The article evaluated long term post-operative results.Six patients were determined to have poor results--with residual regurgitation above "mild" or cardiovascular death.This mdr addresses the four patients with residual regurgitation and a summary table with the associated reporting codes is attached to this filing.The two patients who had cardiovascular deaths were reported in a separate mdr.The article clearly states that any negative events post-operatively were unrelated to aziyo products with statements such as "we had no clear failures related to the patch itself" and "the observed failures were probably unrelated to the [patch] material used." attempts to obtain additional information about the reported events were unsuccessful.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 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: 12143496
• MDR Text Key: 266395658
• Report Number: 3005619880-2021-00026
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• 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: 06/10/2021
• 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): Other