Tyke, Patch, Pledget and Intracardiac CMCV-098-204Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00859389005102), received between Dec 6, 2020 and Dec 6, 2020 — classified as 1 death, 7 injuries.

The most frequently reported specific device problem is “Off-Label Use” (8 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2020Off-Label Use; Off-Label Use

  AS PART OF THE POST MARKET SURVEILLANCE PROCESS, THIS RETROSPECTIVE SINGLE CENTER, SINGLE SURGEON STUDY REPORT PUBLISHED IN PEDIATRIC CARDIOLOGY TITLED "MITRAL VALVE REPLACEMENT IN PEDIATRICS USING AN EXTRACELLULAR MATRIX CYLINDER VALVE: A CASE SERIES" WAS REVIEWED. THIS ARTICLE SUMMARIZES THE RESULTS OF EIGHT (8) CHILDREN UNDER THE AGE OF 2 YEARS WHO UNDERWENT ECM CUSTOM-MADE CYLINDER VALVES FOR MITRAL VALVE REPLACEMENT. THE STUDY STATES THAT THESE PATIENTS WERE TREATED BETWEEN MARCH 2013 AND OCTOBER 2017 USING THE CORMATRIX (NOW AZIYO BIOLOGICS) TYKE 2-PLY EXTRACELLULAR MATRIX MATERIAL (MODEL # / LOT #: UNKNOWN). THIS REPORT IS FOCUSED ON PATIENT #4 AS REFERENCED IN TABLE 1: SUMMARY TABLE OF THE EIGHT PATIENTS WHO INITIALLY UNDERWENT MITRAL VALVE REPAIR HOWEVER UNDER DIRECT INSPECTION, THE SURGEON DETERMINED REPAIR WAS NOT FEASIBLE AND MITRAL VALVE REPLACEMENT WAS PERFORMED. PATIENT #4 WAS IDENTIFIED WITH CONGENITAL MV ARCADE/STENOSIS AND UNDERWENT ECM-MVR AT THE AGE OF 3 MONTHS. AT 5 MONTHS POST-OP, THE PATIENT UNDERWENT BALLOON VALVULOPLASTY DUE TO A MEAN MITRAL VALVE GRADIENT OF 18MMHG. AT 7.9 MONTHS (237 DAYS) POST ECM-MVR REPLACEMENT, THIS PATIENT REQUIRED FURTHER SURGERY TO

  Patient problems: Mitral Valve Insufficiency/ Regurgitation; Mitral Valve Stenosis

  MAUDE report 10955949 ↗
• InjuryDec 6, 2020Off-Label Use; Off-Label Use

  AS PART OF THE POST MARKET SURVEILLANCE PROCESS, THIS RETROSPECTIVE SINGLE CENTER, SINGLE SURGEON STUDY REPORT PUBLISHED IN PEDIATRIC CARDIOLOGY TITLED "MITRAL VALVE REPLACEMENT IN PEDIATRICS USING AN EXTRACELLULAR MATRIX CYLINDER VALVE: A CASE SERIES" WAS REVIEWED. THIS ARTICLE SUMMARIZES THE RESULTS OF EIGHT (8) CHILDREN UNDER THE AGE OF 2 YEARS WHO UNDERWENT ECM CUSTOM-MADE CYLINDER VALVES FOR MITRAL VALVE REPLACEMENT. THE STUDY STATES THAT THESE PATIENTS WERE TREATED BETWEEN MARCH 2013 AND OCTOBER 2017 USING THE CORMATRIX (NOW AZIYO BIOLOGICS) TYKE 2-PLY EXTRACELLULAR MATRIX MATERIAL (MODEL # / LOT #: UNKNOWN). THIS REPORT IS FOCUSED ON THE PATIENT #3 AS REFERENCED IN TABLE 1: SUMMARY TABLE OF THE EIGHT PATIENTS WHO INITIALLY UNDERWENT MITRAL VALVE REPAIR, HOWEVER UNDER DIRECT INSPECTION, THE SURGEON DETERMINED REPAIR WAS NOT FEASIBLE AND MITRAL VALVE REPLACEMENT WAS PERFORMED DUE TO SEVERE LEFT ATRIOVENTRICULAR VALVE REGURGITATION FROM PRIOR FAILED ATRIOVENTRICULAR SEPTAL DEFECT REPAIR. AT THE AGE OF 5.5 MONTHS, ECM-MV REPLACEMENT WAS PERFORMED AND WITHIN DAYS (0.1 MONTHS POST-OP), THE PATIENT DEVELOPED ACUTE DEHISCENCE OF THE PAPILLARY MUSCLE WITH SEVERE REGURGITATION. PATIEN

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 10955938 ↗
• InjuryDec 6, 2020Off-Label Use; Off-Label Use

  AS PART OF THE POST MARKET SURVEILLANCE PROCESS, THIS RETROSPECTIVE SINGLE CENTER, SINGLE SURGEON STUDY REPORT PUBLISHED IN PEDIATRIC CARDIOLOGY TITLED "MITRAL VALVE REPLACEMENT IN PEDIATRICS USING AN EXTRACELLULAR MATRIX CYLINDER VALVE: A CASE SERIES" WAS REVIEWED. THIS ARTICLE SUMMARIZES THE RESULTS OF EIGHT (8) CHILDREN UNDER THE AGE OF 2 YEARS WHO UNDERWENT ECM CUSTOM-MADE CYLINDER VALVES FOR MITRAL VALVE REPLACEMENT. THE STUDY STATES THAT THESE PATIENTS WERE TREATED BETWEEN MARCH 2013 AND OCTOBER 2017 USING THE CORMATRIX (NOW AZIYO BIOLOGICS) TYKE 2-PLY EXTRACELLULAR MATRIX MATERIAL (MODEL # / LOT #: UNKNOWN). THIS REPORT IS FOCUSED ON PATIENT #5 AS REFERENCED IN TABLE 1: SUMMARY TABLE OF THE EIGHT PATIENTS WHO INITIALLY UNDERWENT MITRAL VALVE REPAIR HOWEVER UNDER DIRECT INSPECTION, THE SURGEON DETERMINED REPAIR WAS NOT FEASIBLE AND MITRAL VALVE REPLACEMENT WAS PERFORMED. PATIENT #5 WAS IDENTIFIED WITH CONGENITAL MITRAL REGURGITATION AND ARCADE/STENOSIS UNDERWENT ECM-MV REPLACEMENT AT THE AGE OF 5 MONTHS. AT 6.5 MONTHS POST-OP, THE MEAN MITRAL VALVE INFLOW GRADIENT OF 4MMHG. THIS PATIENT DEVELOPED ACUTE DEHISCENCE OF THE ECM FROM THE POSTERIOR MEDIAL PAPILLARY MUSCLE ATTACHMEN

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 10955937 ↗
• InjuryDec 6, 2020Off-Label Use; Off-Label Use

  AS PART OF THE POST MARKET SURVEILLANCE PROCESS, THIS RETROSPECTIVE SINGLE CENTER, SINGLE SURGEON STUDY REPORT PUBLISHED IN PEDIATRIC CARDIOLOGY TITLED "MITRAL VALVE REPLACEMENT IN PEDIATRICS USING AN EXTRACELLULAR MATRIX CYLINDER VALVE: A CASE SERIES" WAS REVIEWED. THIS ARTICLE SUMMARIZES THE RESULTS OF EIGHT (8) CHILDREN UNDER THE AGE OF 2 YEARS WHO UNDERWENT ECM CUSTOM-MADE CYLINDER VALVES FOR MITRAL VALVE REPLACEMENT. THE STUDY STATES THAT THESE PATIENTS WERE TREATED BETWEEN MARCH 2013 AND OCTOBER 2017 USING THE CORMATRIX (NOW AZIYO BIOLOGICS) TYKE 2-PLY EXTRACELLULAR MATRIX MATERIAL (MODEL # / LOT #: UNKNOWN). THIS REPORT IS FOCUSED ON THE PATIENT #6 AS REFERENCED IN TABLE 1: SUMMARY TABLE OF THE EIGHT PATIENTS WHO INITIALLY UNDERWENT MITRAL VALVE REPAIR, HOWEVER UNDER DIRECT INSPECTION, THE SURGEON DETERMINED REPAIR WAS NOT FEASIBLE AND MITRAL VALVE REPLACEMENT WAS PERFORMED DUE TO ENDOCARDITIS FROM KINGELLA SPECIES OF THE MV WITH REGURGITATION. AT THE AGE OF 15.7 MONTHS, ECM-MV REPLACEMENT WAS PERFORMED AS WELL AS CONCURRENT ASD CREATION, AND AT 15.2 MONTHS POST-OP, THE PATIENT DEVELOPED WORSENING VALVE STENOSIS AND/OR REGURGITATION. PATIENT UNDERWENT A HYBRID SURGICAL PROCE

  Patient problems: Mitral Valve Insufficiency/ Regurgitation; Mitral Valve Stenosis

  MAUDE report 10955934 ↗
• InjuryDec 6, 2020Off-Label Use; Off-Label Use

  AS PART OF THE POST MARKET SURVEILLANCE PROCESS, THIS RETROSPECTIVE SINGLE CENTER, SINGLE SURGEON STUDY REPORT PUBLISHED IN PEDIATRIC CARDIOLOGY TITLED "MITRAL VALVE REPLACEMENT IN PEDIATRICS USING AN EXTRACELLULAR MATRIX CYLINDER VALVE: A CASE SERIES" WAS REVIEWED. THIS ARTICLE SUMMARIZES THE RESULTS OF EIGHT (8) CHILDREN UNDER THE AGE OF 2 YEARS WHO UNDERWENT ECM CUSTOMMADE CYLINDER VALVES FOR MITRAL VALVE REPLACEMENT. THE STUDY STATES THAT THESE PATIENTS WERE TREATED BETWEEN MARCH 2013 AND OCTOBER 2017 USING THE CORMATRIX (NOW AZIYO BIOLOGICS) TYKE 2-PLY EXTRACELLULAR MATRIX MATERIAL (MODEL # / LOT #: UNKNOWN). THIS REPORT IS FOCUSED ON THE PATIENT #7 AS REFERENCED IN TABLE 1: SUMMARY TABLE OF THE EIGHT PATIENTS WHO INITIALLY UNDERWENT MITRAL VALVE REPAIR, HOWEVER UNDER DIRECT INSPECTION, THE SURGEON DETERMINED REPAIR WAS NOT FEASIBLE AND MITRAL VALVE REPLACEMENT WAS PERFORMED DUE TO PRIOR FAILED AVSD REPAIR AND SEVERE LEFT ATRIOVENTRICULAR VALVE REGURGITATION. AT THE AGE OF 6.5 MONTHS, ECM-MV REPLACEMENT WAS PERFORMED AS WELL AS CONCURRENT ASD CREATION. WITHIN DAYS THERE WAS ACUTE DEHISCENCE OF THE PAPILLARY MUSCLE WITH SEVERE REGURGITATION AND THE PATIENTS RUSHED TO SURGERY FO

  Patient problems: Mitral Valve Insufficiency/ Regurgitation; Mitral Valve Stenosis; Thrombosis/Thrombus

  MAUDE report 10955933 ↗
• InjuryDec 6, 2020Off-Label Use; Off-Label Use

  AS PART OF THE POST MARKET SURVEILLANCE PROCESS, THIS RETROSPECTIVE SINGLE CENTER, SINGLE SURGEON STUDY REPORT PUBLISHED IN PEDIATRIC CARDIOLOGY TITLED "MITRAL VALVE REPLACEMENT IN PEDIATRICS USING AN EXTRACELLULAR MATRIX CYLINDER VALVE: A CASE SERIES" WAS REVIEWED. THIS ARTICLE SUMMARIZES THE RESULTS OF EIGHT (8) CHILDREN UNDER THE AGE OF 2 YEARS WHO UNDERWENT ECM CUSTOM-MADE CYLINDER VALVES FOR MITRAL VALVE REPLACEMENT. THE STUDY STATES THAT THESE PATIENTS WERE TREATED BETWEEN MARCH 2013 AND OCTOBER 2017 USING THE CORMATRIX (NOW AZIYO BIOLOGICS) TYKE 2-PLY EXTRACELLULAR MATRIX MATERIAL (MODEL # / LOT #: UNKNOWN). THIS REPORT IS FOCUSED ON PATIENT #8 AS REFERENCED IN TABLE 1: SUMMARY TABLE OF THE EIGHT PATIENTS WHO INITIALLY UNDERWENT MITRAL VALVE REPAIR HOWEVER UNDER DIRECT INSPECTION, THE SURGEON DETERMINED REPAIR WAS NOT FEASIBLE AND MITRAL VALVE REPLACEMENT WAS PERFORMED. PATIENT #8 WAS IDENTIFIED WITH CONGENITAL MITRAL ARCADE/STENOSIS UNDERWENT ECM-MV REPLACEMENT AT THE AGE OF 5.8 MONTHS WITH CONCURRENT ASD CREATION DURING THE PROCEDURE. THIS PATIENT IS CURRENTLY 31 MONTHS POST-OP, AND CURRENTLY HAS TRIVIAL STENOSIS AND REGURGITATION. THE CORMATRIX EMC-MV REMAINS IMPLANTED AN

  Patient problems: Mitral Valve Insufficiency/ Regurgitation; Mitral Valve Stenosis

  MAUDE report 10955931 ↗
• DeathDec 6, 2020Off-Label Use; Off-Label Use

  AS PART OF THE POST MARKET SURVEILLANCE PROCESS, THIS RETROSPECTIVE SINGLE CENTER, SINGLE SURGEON STUDY REPORT PUBLISHED IN PEDIATRIC CARDIOLOGY TITLED "MITRAL VALVE REPLACEMENT IN PEDIATRICS USING AN EXTRACELLULAR MATRIX CYLINDER VALVE: A CASE SERIES" WAS REVIEWED. THIS ARTICLE SUMMARIZES THE RESULTS OF EIGHT (8) CHILDREN UNDER THE AGE OF 2 YEARS WHO UNDERWENT ECM CUSTOM-MADE CYLINDER VALVES FOR MITRAL VALVE REPLACEMENT. THE STUDY STATES THAT THESE PATIENTS WERE TREATED BETWEEN MARCH 2013 AND OCTOBER 2017 USING THE CORMATRIX (NOW AZIYO BIOLOGICS) TYKE 2-PLY EXTRACELLULAR MATRIX MATERIAL (MODEL # / LOT #: UNKNOWN). THIS REPORT IS FOCUSED ON THE PATIENT #2 AS REFERENCED IN TABLE 1: SUMMARY TABLE OF THE EIGHT PATIENTS WHO INITIALLY UNDERWENT MITRAL VALVE REPAIR, HOWEVER DUE TO A SEVERE MITRAL VALVE INJURY DURING THE SAME PROCEDURE, AN ECM MITRAL VALVE WAS PLACED. THE ARTICLE STATES THAT THE HOSPITAL COURSE WAS COMPLICATED BY PROLONGED OPEN CHEST, ATRIAL ARRHYTHMIAS, PULMONARY HYPERTENSION. THIS PATIENT UNDERWENT THE INITIAL MITRAL VALVE REPAIR PROCEDURE AT AGE OF APPROXIMATELY 21 DAYS. AT 3 MONTHS POST-OP, THE POST ECM-MVR REPLACEMENT, THIS PATIENT DEVELOPED SEVERE MITRAL VALVE REGUR

  Patient problems: Atrial Fibrillation; Mitral Valve Insufficiency/ Regurgitation; Respiratory Insufficiency

  MAUDE report 10955908 ↗
• InjuryDec 6, 2020Off-Label Use; Off-Label Use

  AS PART OF THE POST MARKET SURVEILLANCE PROCESS, THIS RETROSPECTIVE SINGLE CENTER, SINGLE SURGEON STUDY REPORT PUBLISHED IN PEDIATRIC CARDIOLOGY TITLED "MITRAL VALVE REPLACEMENT IN PEDIATRICS USING AN EXTRACELLULAR MATRIX CYLINDER VALVE: A CASE SERIES" WAS REVIEWED. THIS ARTICLE SUMMARIZES THE RESULTS OF EIGHT (8) CHILDREN UNDER THE AGE OF 2 YEARS WHO UNDERWENT ECM CUSTOM-MADE CYLINDER VALVES FOR MITRAL VALVE REPLACEMENT. THE STUDY STATES THAT THESE PATIENTS WERE TREATED BETWEEN MARCH 2013 AND OCTOBER 2017 USING THE CORMATRIX (NOW AZIYO BIOLOGICS) TYKE 2-PLY EXTRACELLULAR MATRIX MATERIAL (MODEL # / LOT #: UNKNOWN). THIS REPORT IS FOCUSED ON THE PATIENT #1 AS REFERENCED IN TABLE 1: SUMMARY TABLE OF THE EIGHT PATIENTS WHO INITIALLY UNDERWENT MITRAL VALVE REPAIR HOWEVER UNDER DIRECT INSPECTION, THE SURGEON DETERMINED REPAIR WAS NOT FEASIBLE AND MITRAL VALVE REPLACEMENT WAS PERFORMED. PATIENT #1 WAS IDENTIFIED WITH CONGENITAL MV ARCADE/STENOSIS AND FOLLOWING IMPLANT UNDERWENT ECM-MVR AT THE AGE OF (B)(6). AT APPROXIMATELY (B)(6) POST ECM-MVR REPLACEMENT, THIS PATIENT REQUIRED FURTHER SURGERY TO IMPLANT A REPLACEMENT MITRAL VALVE (ON-X MECHANICAL VALVE) AND EXPLANTING THE ECM MITRAL VAL

  Patient problems: Mitral Valve Insufficiency/ Regurgitation; Mitral Valve Stenosis

  MAUDE report 10955907 ↗