Epic™ E100-27M-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05414734055574), received between Sep 18, 2018 and Aug 24, 2026 — classified as 1 death, 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Intravalvular regurgitation” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2026Intravalvular regurgitation

  It was reported that on (b)(6) 2022, a 27mm Epic Valve was implanted in the patient. It was reported that on (b)(6) 2026, the patient presented with shortness of breath and an increase in mitral regurgitation (MR) was noted. A redo procedure was scheduled. The excision date is unknown because it was performed at another hospital. The patient is stable and under observation.

  Patient problems: Dyspnea; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 50420817 ↗
• InjuryJul 2, 2024Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2020, A 27MM EPIC VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. ON (B)(6) 2023, IT WAS NOTED THAT THE PATIENT'S LAB RESULTS WERE CONSISTENT WITH MODERATE HEMOLYSIS. ON (B)(6) 2023, A TRANSESOPHAGEAL ECHOCARDIOGRAM WAS PERFORMED AND REVEALED A PERIVALVULAR LEAK (PVL) OF THE 27MM EPIC VALVE. ON (B)(6) 2023, THE DECISION WAS MADE TO IMPLANT A 12X3MM AMPLATZER VALVULAR PLUG 3 FOR CLOSURE OF THE PVL. THE PATIENT REPORTS INTERMITTENT FATIGUE AND DYSPNEA ON EXERTION AT THE TIME OF REPORT. THE PATIENT IS PENDING A FOLLOW UP WITH CARDIOTHORACIC SURGERY TO DISCUSS/SCHEDULE FURTHER INTERVENTION. THE CAUSE OF THE PVL IS ATTRIBUTED TO MITRAL ANNULAR CALCIFICATION.

  Patient problems: Anemia; Hemolysis

  MAUDE report 19656268 ↗
• InjuryFeb 24, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, A 27MM EPIC VALVE WAS SELECTED FOR IMPLANTED IN A PATIENT WITH SEVERE DYSPNEA WITH LIMITED EXERTION, DENSE MITRAL ANNULAR CALCIFICATION AND SEVERE CALCIFIC MITRAL STENOSIS. THE PATIENT WAS HEPARINIZED COMPLETELY AND THE ACT WAS CONFIRMED TO BE OVER 400. THE 27MM EPIC VALVE WAS IMPLANTED IN A SUPRAANNULAR FASHION. A CONCOMITANT PROCEDURE WAS PERFORMED USING A 40MM NON ABBOTT DEVICE TO OCCLUDED THE LEFT ATRIAL APPENDAGE. THE PATIENT WAS WEANED OFF CARDIOPULMONARY BYPASS WITHOUT DIFFICULTY. REPEAT TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED WELL FUNCTIONING PROSTHESIS, NO PARAVALVULAR LEAK AND NO CHANGE IN THE LEFT VENTRICLE FUNCTION. THERE WAS MINIMAL GRADIENT ACROSS THE BIOPROSTHETIC VALVE. THE PROCEDURE WAS TOLERATED WELL AND THE PATIENT WAS TRANSFERRED INTO THE INTENSIVE CARE UNIT IN CRITICAL BUT STABLE CONDITION. THE PATIENT EXPERIENCE CONFUSION AND AGITATION FOR TWO DAYS POST OPERATIVELY. THE PATIENT WAS MOVING ALL EXTREMITIES ON COMMAND AND HEART RHYTHM WAS SINUS RHYTHM WITH ATRIOVENTRICULAR BLOCK. ON POST OPERATIVE DAY THREE, THE PATIENT EXPERIENCED SUPRAVENTRICULAR TACHYCARDIA AND WAS STARTED ON AN AMIODARONE DRIP. PATIENT WAS SEEN BY PSYCHIATRY

  Patient problems: Arrhythmia; Fatigue; Heart Block; Pain

  MAUDE report 16436543 ↗
• DeathNov 23, 2022Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT ON 21 OCTOBER 2021, A 21MM NON-ABBOTT AORTIC VALVE AND A 27MM EPIC MITRAL VALVE WERE SUCCESSFULLY IMPLANTED IN A DOUBLE VALVE REPLACEMENT SURGERY. ON (B)(6) 2022, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR SHORTNESS OF BREATH WORSENING ON EXERTION, PROGRESSIVE RESPIRATORY DISTRESS, AND PULMONARY EDEMA. THE PATIENT HAD A TRANSESOPHAGEAL ECHOCARDIOGRAM TO EVALUATE THE MITRAL VALVE PROSTHESIS AND LEFT VENTRICULAR FUNCTION. THE MEAN GRADIENT OF THE MITRAL VALVE WAS 21MMHG, WHICH WAS CLASSIFIED AS SEVERE MITRAL STENOSIS. THE PEAK INFLOW VELOCITY WAS 284 CM/SEC. THE DOPPLER VELOCITY INDEX (DVI) WAS 2.9. THE EFFECTIVE ORIFICE AREA (EOA) WAS 0.5 CM^2. THE MITRAL VALVE PRESSURE HALF TIME WAS 229 MS. DURING PRE-OPERATIVE WORK-UP WHILE THE PATIENT WAS HOSPITALIZED, THE PATIENT WAS INTUBATED DUE TO RESPIRATORY DISTRESS, AND THE PATIENT WENT INTO CARDIAC ARREST POST INTUBATION. THE CAUSE OF DEATH WAS PULSELESS ELECTRICAL ACTIVITY (PEA). THE PATIENT DIED ON (B)(6) 2022. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adult Respiratory Distress Syndrome; Cardiac Arrest; Dyspnea; Heart Failure/Congestive Heart Failure; Mitral Valve Stenosis; Pulmonary Edema

  MAUDE report 15857898 ↗
• MalfunctionNov 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2022, A 27MM EPIC VALVE WAS SELECTED FOR PROCEDURE. IT WAS NOTED DURING PROCEDURE THAT THE VALVE HOLDER DISASSEMBLED WHEN ATTEMPTING TO REMOVE THE VALVE HOLDER FROM THE EPIC VALVE WHILE THE VALVE WAS SEATED IN THE PATIENT'S ANNULUS. IT WAS NOTED THAT A SMALL SPRING AND OTHER PIECES FELL ONTO THE SURGICAL FIELD. THE SMALL SPRING AND PIECES WERE REMOVED FROM THE SURGICAL FIELD. THE 27MM EPIC VALVE WAS SUCCESSFULLY IMPLANTED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATION. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT WAS RECOVERING AND NEUROLOGICALLY STABLE AT THE TIME OF REPORT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15737344 ↗
• MalfunctionSep 14, 2022Perivalvular Leak; Intravalvular regurgitation; Perivalvular Leak; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2022, A 27MM EPIC MITRAL VALVE WAS IMPLANTED. AFTER THE VALVE WAS IMPLANTED, IT WAS OBSERVED ON ECHOCARDIOGRAM THAT THERE WAS A LEAK FROM THE VALVE. THE DECISION WAS MADE TO REMOVE THE VALVE AND REPLACE IT WITH ANOTHER VALVE. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15420143 ↗
• InjuryNov 18, 2020Backflow; Material Split, Cut or Torn; Backflow; Material Split, Cut or Torn

  ON (B)(6) 2020, A 27MM EPIC STENTED MITRAL HEART VALVE WAS IMPLANTED. ON (B)(6) 2020, THE PATIENT PRESENTED TO OUTSIDE HOSPITAL WITH DYSPNEA AND WAS FOUND TO BE IN HYPOXIC RESPIRATORY FAILURE REQUIRED INTUBATION. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO THE HOSPITAL. THE VALVE WAS EVALUATED AND IT WAS DETERMINED THAT THE VALVE HAD FAILED, FURTHER DESCRIBED AS "DEHISCENCE OF THE PROSTHESIS, SEVERE MITRAL VALVE REGURGITATION," AND REQUIRED REPLACEMENT. THE PATIENT STATUS WAS REPORTED AS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER WAS UNAVAILABLE.

  Patient problems: Dyspnea; Hypoxia; Mitral Regurgitation

  MAUDE report 10864017 ↗
• InjuryApr 24, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2019, A 27MM EPIC VALVE WAS SELECTED FOR IMPLANT IN A MITRAL VALVE REPLACEMENT AND CRYOMAZE ABLATION PROCEDURE. POST BYPASS TEE SHOWED GRADE 2+ INTRAVALVULAR LEAKAGE AT THE STENT POST. THE VALVE WAS REMOVED AND A 27MM MEDTRONIC MOSAIC TISSUE VALVE WAS IMPLANTED. BYPASS TIME WAS PROLONGED BY 66 MINUTES. THE PATIENT HAS BEEN DISCHARGED.

  Patient problems: Mitral Insufficiency

  MAUDE report 8546936 ↗
• InjurySep 18, 2018Leak/Splash; Leak/Splash

  ON (B)(6) 2015, A 19MM TRIFECTA VALVE WAS IMPLANTED. ON AN UNKNOWN DATE IN (B)(6), THE PATIENT VISITED THE HOSPITAL AND THE PHYSICIAN OBSERVED A FAILING VALVE. ON (B)(6) 2018, REDO AORTIC VALVE REPLACEMENT AND MITRAL VALVE REPLACEMENT WAS COMPLETED. THE 19MM TRIFECTA VALVE WAS EXPLANTED AND A 21MM TRIFECTA GT WAS IMPLANTED IN THE AORTIC POSITION. THE EXPLANTED VALVE WAS NOTED TO HAVE PANNUS ON THE VALVE. CONCOMITANTLY, A 27MM EPIC VALVE WAS IMPLANTED IN THE MITRAL POSITION. UPON BYPASS TERMINATION, TEE OBSERVED A DIRECTIONAL JET FROM THE MITRAL VALVE. DUE TO SURGICALLY RELATED EDEMA, THE 27MM EPIC VALVE WAS EXCHANGED FOR A 25MM EPIC VALVE AND TEE SHOWED GOOD RESULTS. THE PATIENT IS DISCHARGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7886886 ↗