ProxiCor for Cardiac Tissue Repair CMCV-064-401Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00859389005041), received between Jan 13, 2017 and Sep 30, 2020 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Delamination” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathSep 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 6/18/2020, AZIYO BIOLOGICS CONTRACT MANUFACTURER NOTIFIED AZIYO OF A RECENTLY ACCEPTED FOR PRINT ARTICLE IN PACING AND CLINICAL ELECTROPHYSIOLOGY (PACE) [REFERENCE: PACING CLIN ELECTROPHYSIOL. 2020 JUN 16. DOI: 10.1111/PACE.13988. ONLINE AHEAD OF PRINT]. THE ARTICLE TITLED "SURGICAL AND ENDOSCOPIC MANAGEMENT OF A PERICARDIOESOPHAGEAL FISTULA AFTER RADIOFREQUENCY PULMONARY VEIN ISOLATION MANAGEMENT OF A PERICARDIOESOPHAGEAL FISTULA" WAS EPUBLISHED ON JUNE 16, 2020. THIS ARTICLE WAS DISCOVERED DURING THE CONTRACT MANUFACTURER'S LITERATURE REVIEW CYCLE AND REVIEWED IN SUPPORT OF AZIYO BIOLOGICS POST MARKET SURVEILLANCE PROCESS. THE CASE STUDY REPORTS THE EVENTS RELATIVE TO A (B)(6) YEAR OLD MALE PATIENT HAVING PREVIOUSLY UNDERGONE AN RF PULMONARY VEIN ISOLATION PROCEDURE 3 WEEKS PRIOR, PRESENTED WITH CHEST PAIN. CTA AND ECHOCARDIOGRAM SHOWED PNEUMOPERICARDIUM AND BARIUM ESOPHAGRAM SHOWED EXTRAVASATION FROM ESOPHOGUS INTO THE PERICARDIUM WITHOUT CONNECTION TO THE LEFT ATRIUM. PERICARDIAL DEFECT WAS IDENTIFIED AND A CORMATRIX (NOW AZIYO BIOLOGICS INC.) PROXICOR ECM PATCH WAS PLACED (MODEL #: UNKNOWN, LOT #: UNKNOWN - LIKELY PROXICOR FOR CARDIAC TISSUE REPAIR). THE FISTULA RESULTING F

  Patient problems: Cardiac Arrest; Drug Resistant Bacterial Infection

  MAUDE report 10608322 ↗
• InjuryAug 7, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A COMPLEX AORTIC VALVE REPAIR ON (B)(6) 2016. THE CORMATRIX ECM FOR CARDIAC TISSUE REPAIR WAS SOAKED IN A SALINE SOLUTION FOR 1 MINUTE. ON (B)(6) 2019 (PATIENT REPORTED AS (B)(6) YEARS OLD AT TIME OF EVENT) DUE TO RECURRENT CENTRAL AORTIC INSUFFICIENCY HE NEEDED TO BE RE-OPERATED FOR A ROSS PROCEDURE. A REPLACEMENT OF THE AORTIC VALVE WITH PULMONARY AUTOGRAFT WAS COMPLETED. IT CAN BE NOTED THAT THE PATIENT HAS DYSPLASTIC AORTIC VALVE AND COULD HAVE CONTRIBUTED TO THE EVENT. PROBABLE CAUSE OF THE EVENT WAS LISTED AS DELAMINATION OF THE ECM CAUSING CALCIFICATION AND LEAFLET IMMOBILITY. THE SITE STATES THAT THE EVENT IS PROBABLY RELATED TO THE PROCEDURE AND PROBABLY RELATED TO THE ECM DEVICE. THE DELAMINATION OF THE ECM MATERIAL WAS THOUGHT TO BE IN RELATION TO THE PATIENT COMORBIDITIES AND BOUGHT THE PATIENT MORE TIME BEFORE THE NEXT PROCEDURE (ROSS). THE PHYSICIANS WERE SATISFIED WITH THE OUTCOME.

  Patient problems: Aortic Insufficiency; Foreign Body Reaction; Inflammation

  MAUDE report 8870610 ↗
• MalfunctionJan 13, 2017Delamination; Delamination

  IT WAS REPORTED THAT ON (B)(6) 2016, A 7CM X 10CM CORMATRIX ECM FOR CARDIAC TISSUE REPAIR (CMCV-064-401 LOT# M16H1192) WAS BEING PREPARED FOR A PULMONIC VALVE APPLICATION (OFF-LABEL USE) ON THE "DRY TABLE'. THE 7CM X 10CM PIECE OF TISSUE WAS OBSERVED TO BE UNUSUALLY THICK, AND THEN THE TISSUE SEPARATED INTO TWO LAYERS. THE ECM TISSUE HAD NOT BEEN HYDRATED AT THE TIME OF OBSERVING THE DELAMINATION. THE SURGEON ABANDONED CREATING THE VALVE WITH THIS PIECE OF TISSUE, AND PROCEEDED TO TAKE ANOTHER 7CM X 10CM PACKAGE OF CORMATRIX ECM FOR CARDIAC TISSUE REPAIR FROM THE SHELF AND COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 6251921 ↗