Epic™ E100-33M-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05414734055611), received between Jan 24, 2019 and Jan 16, 2025 — classified as 1 death, 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Intravalvular regurgitation” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 33MM EPIC MITRAL VALVE WAS IMPLANTED IN THE PATIENT. ON AN UNKNOWN DATE, MITRAL STENOSIS/MITRAL REGURGITATION, MIXED DYSFUNCTION AND APPARENT FOREIGN BODY ON THE VALVE PROSTHESIS WERE NOTED. ON (B)(6)2024, THE VALVE WAS EXPLANTED AND N 31MM NON-ABBOTT VALVE WAS IMPLANTED.

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

  MAUDE report 21173539 ↗
• InjuryDec 16, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, A 33MM EPIC VALVE WAS IMPLANTED IN THE PATIENT. ON AN UNKNOWN DATE, SEVERE PROSTHETIC VALVE DETERIORATION WITH SEVERE MITRAL REGURGITATION WAS NOTED BUT NO ACTIVE EVIDENCE OF ENDOCARDITIS. THE VALVE WAS EXPLANTED AND A 33MM NON-ABBOTT VALVE WAS IMPLANTED. THE EXPLANTED VALVE HAD THICKENED LEAFLETS. THE PATIENT WAS REPORTED STABLE AND RECOVERING.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 20945324 ↗
• InjuryMar 18, 2024Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON 22 FEBRUARY 2024, A 33MM EPIC MITRAL VALVE WAS CHOSEN FOR IMPLANT. THE PATIENT WAS PRESENTED WITH A NON-ABBOTT ANNULOPLASTY RING THAT WAS PLACED 10 YEARS AGO. DURING THE PROCEDURE, THE EPIC VALVE WAS IMPLANTED, USING A TOTAL OF 27 STITCHES. AFTER COMING OFF CARDIOPULMONARY BYPASS, THE PATIENT WAS FOUND TO HAVE MILD CENTRAL MITRAL VALVE REGURGITATION (MR). CONSIDERING THE ADDITIONAL RISKS FOR REPLACING THE IMPLANTED VALVE, A DECISION WAS MADE TO NOT EXPLANT THE VALVE ALTHOUGH THE PRESENCE OF MILD MR WAS CONSIDERED UNACCEPTABLE. THE PATIENT WAS REPORTED TO BE DISCHARGED. THE MR PRIOR TO DISCHARGE WAS OBSERVED TO BE AT GRADE MILD-TRACE.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 18923664 ↗
• InjuryOct 11, 2023Use of Device Problem; Patient-Device Incompatibility; Patient Device Interaction Problem; Use of Device Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A 33MM EPIC MITRAL VALVE WAS IMPLANTED IN A PATIENT DURING A MITRAL VALVE REPLACEMENT. ON (B)(6) 2023, PATIENT WAS ADMITTED IN THE HOSPITAL. ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH STROKE AND IT WAS NOTED THAT THE VALVE WAS CAUGHT UP IN THE PAPILLARY MUSCLES. THE VALVE DID NOT MIGRATE. THE PHYSICIAN THOUGHT IT WAS OVERSIZED BECAUSE THE PATIENT WAS SMALL AND THE ANNULUS AND VENTRICLE WERE SMALL. THERE WAS PANNUS ON THE VALVE AND THE VALVE STENT POST SCARRED OVER THE VENTRICULAR WALL. ON 15 SEPTEMBER 2023, THE VALVE WAS EXPLANTED. IN THE EXPLANTED VALVE, IT WAS NOTED THAT THE SCAR TISSUE AND PANNUS OVERGROWTH PREVENTED NORMAL LEAFLET FUNCTION AND LEAD TO THROMBOSIS. A NEW 29MM EPIC MITRAL VALVE WAS IMPLANTED.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 17916277 ↗
• InjuryMay 18, 2023Material Split, Cut or Torn; Intravalvular regurgitation; Material Split, Cut or Torn; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2016, A 33MM EPIC MITRAL VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. ON A LATER DATE, THE PATIENT RETURNED WITH SHORTNESS OF BREATH AND HEART FAILURE SYMPTOMS. AN ECHOCARDIOGRAM REVEALED SEVERE MITRAL REGURGITATION. ON (B)(6) 2023, THE VALVE WAS EXPLANTED AND REPLACED WITH A 31MM EPIC MITRAL VALVE. IT WAS REPORTED THAT ONE LEAFLET ON THE VALVE WAS TORN ALONG THE COMMISSURE AND WAS FLAILING. OTHER LEAFLETS APPEARED NORMAL. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 16954037 ↗
• InjuryDec 22, 2022Patient-Device Incompatibility; Intravalvular regurgitation; Patient-Device Incompatibility; Intravalvular regurgitation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 33MM EPIC VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. ON (B)(6) 2022, IT WAS NOTED THAT THE PATIENT WAS SUFFERING FROM DEVICE RELATED ENDOCARDITIS. IT WAS ALSO NOTED THAT THE PATIENT HAD MITRAL REGURGITATION. THE DECISION WAS MADE TO EXPLANT AND REPLACE THE 33MM EPIC VALVE WITH AN UNKNOWN SIZE NON-ABBOTT DEVICE. THE PATIENT STATUS WAS REPORTED AS UNKNOWN.

  Patient problems: Endocarditis; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 16038099 ↗
• InjurySep 22, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 33MM EPIC STENTED PORCINE VALVE WAS IMPLANTED APPROXIMATELY 4 YEARS AGO. ON (B)(6) 2022, THE VALVE WAS EXPLANTED BECAUSE "IT WAS DEFECTIVE." THE DEFECT IS UNKNOWN. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15464896 ↗
• MalfunctionJul 28, 2022Product Quality Problem; Insufficient Device Problem Information; Product Quality Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2022, A 33MM EPIC VALVE WAS SELECTED FOR PROCEDURE. IT WAS NOTED THAT AT AN UNKNOWN POINT DURING THE PROCEDURE THE EPIC VALVE SEEMED TO "FALL APART." THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 15126315 ↗
• InjuryOct 26, 2020Backflow; Backflow

  ON (B)(6) 2020, A 33 MM EPIC MITRAL TISSUE VALVE WAS SIZED AND CHOSEN FOR PROCEDURE. AFTER COMING OFF BYPASS AND REVIEWING THE VALVES FUNCTION DURING AN INTRA-OPERATIVE ECHO, THE VALVE APPEARED TO HAVE SOME ECCENTRIC MR THROUGH THE VALVE. THE SURGEON DECIDED TO GO BACK ON BYPASS AND REMOVE THE VALVE. THE VALVE WAS REPLACED WITH A 31MM EPIC MITRAL VALVE AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. PATIENT IS STABLE AND RECOVERING.

  Patient problems: Mitral Regurgitation

  MAUDE report 10734126 ↗
• MalfunctionJul 21, 2020Backflow; Incomplete Coaptation; Backflow; Incomplete Coaptation

  ON (B)(6) 2020, AN EPIC MITRAL VALVE WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, REGURGITATION WAS OBSERVED DUE TO INCOMPLETE COAPTATION OF THE VALVE. THE DEVICE WAS EXCHANGED INTRAOPERATIVELY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS A CLINICALLY SIGNIFICANT DELAY.

  Patient problems: Mitral Regurgitation

  MAUDE report 10305722 ↗
• InjuryJan 31, 2019Microbial Contamination of Device; Microbial Contamination of Device

  A PATIENT HAD A CRMD HIGH VOLTAGE DEVICE IMPLANTED ON (B)(6) 2013 WHICH WAS EXPLANTED ON (B)(6) 2018 WITH INFORMATION ON REPLACEMENT NOT MADE AVAILABLE. THEN ON (B)(6) 2017, THE PATIENT HAD A 33MM EPIC VALVE AND 27MM TRIFECTA GT IMPLANTED. ON AN UNKNOWN DATE, THE PATIENT WAS REPORTED WITH ENDOCARDITIS AND DIAGNOSED WITH SEPSIS. ON (B)(6) 2018, THE PATIENT PASSED AWAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Death; Endocarditis; Sepsis

  MAUDE report 8294944 ↗
• DeathJan 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018, A 33M WAS IMPLANTED AND RECOVERED AND WAS DISCHARGED. ON 08 JANUARY 2019, ABBOTT WAS MADE AWARE FROM PATIENT DEVICE TRACKING THAT THE PATIENT EXPIRED AT ANOTHER FACILITY ON (B)(6) 2018. INFORMATION FROM THE IMPLANTING SURGEON INDICATED THAT THE PATIENT WAS SEEN ON (B)(6) 2018 AND HAD NO EVIDENCE OF A DEVICE MALFUNCTION WAS NOTED. PER THE FAMILY, IT IS REPORTED THAT THE "VALVE WAS NOT WORKING AS EXPECTED' HOWEVER THE FACILITY WHERE THE PATIENT DIED DID NOT PROVIDE ABBOTT ANY INFORMATION AND DUE TO PRIVACY RESTRICTIONS, ABBOTT WAS UNABLE TO OBTAIN ADDITIONAL INFORMATION.

  Patient problems: Death

  MAUDE report 8276175 ↗