Epic™ E100-31M-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05414734055604), received between Jan 5, 2017 and Aug 20, 2024 — classified as 2 deaths, 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (3 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2024Degraded; Intravalvular regurgitation; Degraded; Intravalvular regurgitation

  IT WAS REPORTED THAT IN (B)(6) 2021, A 31MM EPIC VALVE WAS IMPLANTED. ONE YEAR POST IMPLANT, THE PATIENT BEGAN SUFFERING FROM SHORTNESS OF BREATH, LACK OF STAMINA, AND GENERALLY FEELING POORLY. A TEE WAS PERFORMED AND REVEALED THAT THE MITRAL VALVE WAS LEAKING BACKWARDS. IN (B)(6) 2024, A VALVE-IN-VALVE PROCEDURE WAS CONDUCTED USING A NON-ABBOTT VALVE. THE PROCEDURE WENT WELL WITH NO COMPLICATIONS. THE PATIENT IS STABLE, BUT WAS NOTED TO HAVE BALANCE PROBLEMS. IT'S UNSURE NOT SURE IF THIS IS RELATED TO THE DEVICE.

  Patient problems: Dyspnea; Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 20007202 ↗
• InjuryMay 9, 2023Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE A 31MM EPIC VALVE WAS SELECTED FOR IMPLANT. AFTER IMPLANTATION IT WAS THOUGHT THAT A LARGE CENTRAL JET WAS SEEN AFTER THE PATIENT WAS COMING OFF THE PUMP. THE VALVE WAS REPLACED WITH AN UNKNOWN DEVICE. PATIENT STATUS IS UNKNOWN.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 16896622 ↗
• MalfunctionMar 21, 2022Break

  AFTER VALVE WAS IMPLANTED, HOLDER FELL APART. FDA SAFETY REPORT ID#:(B)(4).

  Patient problems: Insufficient Information

  MAUDE report 13847463 ↗
• InjuryMar 9, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ON (B)(6) 2021, A 31 MM EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM WAS SUCCESSFULLY IMPLANTED. DURING POST-OP ECHO, THE SURGEON DIDN'T LIKE THE WAY THE VALVE WAS SITTING. THE VALVE WAS REMOVED AND ANOTHER 31 MM EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM WAS IMPLANTED. THERE IS NO ALLEGATION OF MALFUNCTION AGAINST THE ABBOTT DEVICE. THE PATIENT IS RECOVERING WITH NO ADVERSE HEALTH CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11449454 ↗
• InjuryNov 9, 2020Backflow; Incomplete Coaptation; Backflow; Incomplete Coaptation

  A 31MM EPIC MITRAL WAS IMPLANTED IN A DOUBLE VALVE PROCEDURE AND WHEN THE PATIENT CAME OF BYPASS, THE LEAFLETS WERE NOT COAPTING. THIS CREATED A MITRAL REGURGITATION (MR) AND HE WAS FORCED TO GO BACK ON PUMP AND REMOVE THE VALVE. A UNKNOWN EDWARDS VALVE WAS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10809075 ↗
• InjuryOct 23, 2020Gradient Increase; Obstruction of Flow; Gradient Increase; Obstruction of Flow

  ON (B)(6) 2020, A 31MM EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM WAS SELECTED FOR IMPLANT. AFTER PLACING THE VALVE THE SURGEON NOTED LVOT (LEFT VENTRICULAR OUTFLOW TRACT) OBSTRUCTION THAT WAS CAUSING ELEVATED GRADIENT. THE PATIENT WAS PLACED BACK ON THE PUMP AND THE VALVE WAS EXPLANTED AND REPLACED WITH A 29MM EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10727524 ↗
• InjurySep 30, 2020Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 2020, A 31MM EPIC MITRAL VALVE WAS SELECTED FOR IMPLANT. IT WAS REPORTED THAT THE IMPLANT WENT WELL AND THE VALVE WAS TESTED WITH SALINE AND THE LEAFLETS WERE COAPTING. AS THE PATIENT WAS COMING OFF BYPASS, ALL LEAFLETS WERE OBSERVED TO BE FUNCTIONING AND COAPTING, HOWEVER A LARGE CENTRAL JET WAS OBSERVED ON ECHO. CLOSER EXAMINATION SHOWED THAT ONE OF THE LEAFLETS APPEARED TO BE PROLAPSING. NO PARAVALVULAR LEAK WAS OBSERVED, NO PERFORATION OF ANY LEAFLET WAS OBSERVED, AND NO LEAFLET WAS SUTURE LOOPED. THE PATIENT WAS TAKEN FULLY OFF OF BYPASS AND FULLY PRESSURIZED AND THE VALVE DID NOT IMPROVE. THE EPIC VALVE WAS INTRAOPERATIVELY EXPLANTED AND A COMPETITOR'S 25MM MAGNA EASE VALVE WAS SUCCESSFULLY IMPLANTED. UPON EXPLANT OF THE EPIC VALVE, THE PHYSICIAN REPORTED THAT ONE OF THE LEAFLETS WAS SHORT OF FULL COAPTATION. THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PHYSICIAN DOES ALLEGE A CLINICALLY SIGNIFICANT PROLONGED PROCEDURE TIME DUE TO THE EXCHANGE. THE PATIENT WAS REPORTED TO BE RECOVERING WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10608254 ↗
• MalfunctionJul 16, 2020Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 2020, A 31MM EPIC MITRAL VALVE AND A 23 MM TRIFECTA GT VALVE WERE CHOSEN FOR PROCEDURE. POST PROCEDURE, ON ECHO, THE PHYSICIAN OBSERVED WHAT APPEARED TO BE ONE LEAFLET NOT COAPTING COMPLETELY WITH THE EPIC MITRAL VALVE AND CAUSING SOME MILD TO MODERATE MR. THEY CONTINUED TO OBSERVE AND NOTED THIS ON ECHO BUT CHOSE TO LEAVE THE VALVE IN PLACE WITH NO FURTHER ACTION. THE CASE WAS COMPLETED AND PATIENT IS RECOVERING. ON (B)(6) 2020 THE SURGEON REPORTED THEY PERFORMED ANOTHER ECHO THAT AFTERNOON WHICH REVEALED THE MODERATE MR STILL PRESENT. NO FURTHER ACTION HAS BEEN COMPLETED AT THIS TIME AS THE PATIENT IS 74 YEARS OLD AND IT IS THOUGHT THAT THE PATIENT MAY NOT TOLERATE ANOTHER PROCEDURE WELL. A COPY OF THE OR REPORT HAS BEEN REQUESTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 10283392 ↗
• MalfunctionApr 6, 2020Backflow; Backflow

  ON (B)(6) 2020, A 31MM EPIC VALVE WAS SELECTED FOR IMPLANT. AFTER COMING OFF BYPASS, THE VALVE WAS OBSERVED TO HAVE A REGURGITATION JET ON TRANSESOPHAGEAL ECHO (TEE). THE PATIENT WAS PUT BACK ON BYPASS AND THE VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER 31MM EPIC MITRAL VALVE. THE PATIENT IS CURRENTLY RECOVERING.

  Patient problems: Regurgitation

  MAUDE report 9931805 ↗
• InjuryApr 1, 2020Perivalvular Leak; Perivalvular Leak

  ON (B)(6) 2020, A 31MM EPIC VALVE WAS SELECTED FOR IMPLANT. THE VALVE WAS FULLY IMPLANTED AND THE SURGEON ELECTED TO PRESSURE TEST THE VALVE WHILE THE PATIENT WAS ON BYPASS. THE SURGEON WAS NOT COMFORTABLE WITH THE WAY THE VALVE LOOKED; IT WAS REPORTED THERE WAS LEAK WHEN THE VENTRICLE WAS PRESSURIZED. THE VALVE WAS INTRA-OPERATIVELY EXPLANTED AND A NEW 31MM EPIC VALVE WAS SUCCESSFULLY IMPLANTED. IT WAS REPORTED THAT THERE WAS A CLINICALLY SIGNIFICANT PROLONGED PROCEDURE TIME DUE TO THE EXCHANGE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9910560 ↗
• InjuryAug 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, A 31MM EPIC WAS IMPLANTED. WHEN OBSERVING THE VALVE ON THE POST-"O[" ECHOCARDIOGRAM THE VALVE WAS OBSERVED TO HAVE MODERATE MITRAL REGURGITATION. THE PATIENT WAS PLACED ON BYPASS AND THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 31MM EPIC VALVE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES; HOWEVER, THERE WAS ADDITIONAL BYPASS TIME.

  Patient problems: Mitral Regurgitation; No Known Impact Or Consequence To Patient

  MAUDE report 8881048 ↗
• DeathMar 28, 2019Missing Information; Missing Information

  INFORMATION FROM A PATIENT DEVICE TRACKING FORM REPORTS ON (B)(6) 2018, A 31MM EPIC VALVE WAS IMPLANT. A NOTE ON THE FORM STATES THAT THE PATIENT PASSED AWAY SHORTLY AFTER SURGERY. ADDITIONAL INFORMATION REGARDING THIS EVENT WAS REQUESTED WITH MULTIPLE ATTEMPTS, BUT NOT MADE AVAILABLE BY THE PHYSICIAN OR HOSPITAL.

  Patient problems: Death

  MAUDE report 8460845 ↗
• DeathFeb 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2014, A 31MM EPIC VALVE WAS IMPLANTED IN THE MITRAL POSITION. AFTER SEVERAL MONTHS, THE PATIENT PRESENTED IN (B)(6) 2014 & WAS REPORTED AS NOT FEELING WELL. THE PATIENT HAD HEMOLYTIC ANEMIA, RIGHT ARM WEAKNESS, CONFUSION AND EVIDENCE OF A TIA. THE PATIENT WAS ALSO DIAGNOSED WITH AORTIC VALVE DISEASE AND ASSESSED FOR ENDOCARDITIS, THERE WAS A PARAVALVULAR MITRAL LEAK WITH REGURGITATION. INITIALLY THE PLAN WAS TO RE-OPERATE AFTER 6 WEEKS OF ANTIBIOTICS AND CARE. ON (B)(6) 2014, THE MITRAL VALVE WAS EXPLANTED, IT WAS STRUCTURALLY INTACT WITHOUT APPARENT ENDOCARDITIS. THE PATIENT ALSO RECEIVED AN AORTIC VALVE FROM ANOTHER MANUFACTURER AS WELL. THERE WAS EVIDENCE OF UNHEALTHY TISSUE BUT NO VEGETATION IN THE VALVE. ON (B)(6) 2017, THE PATIENT EXPIRED. PER THE CERTIFICATE OF DEATH, THE CAUSE OF DEATH WAS CARDIAC ARREST, METABOLIC ACIDOSIS, AND NECROTIC BOWEL. THE MANNER OF DEATH WAS DEEMED NATURAL.

  Patient problems: Cardiac Arrest; Death; Stroke/CVA; Unspecified Infection

  MAUDE report 8320109 ↗
• InjuryJan 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018, A 31MM EPIC VALVE WAS IMPLANTED. ON (B)(6) 2019, ABBOTT WAS MADE AWARE FROM PATIENT DEVICE TRACKING THAT THE PATIENT EXPIRED. THE DATE OF DEATH WAS (B)(6) 2018. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Death

  MAUDE report 8273285 ↗
• InjuryJan 5, 2017Folded; Torn Material

  PT SCHEDULED FOR AVR/MVR+/- TVR. AFTER REPLACING THE MITRAL VALVE W31 MM, ST JUDE MEDICAL EPIC VALVE, AS THE VALVE WAS BEING TREATED, A TEAR WAS NOTED IN ONE OF THE LEAFLETS. THE VALVE WAS EXPLANTED. ALL 10 OF THE COR-KNOTS AND ALL 10 OF THE PLEDGETS FROM THE SUTURES USED TO SECURE THE VALVE IN PLACE WERE REMOVED AND DISCARDED ON INSPECTING THE EXPLANTED VALVE THE DOCTOR NOTICED THAT THERE WAS A FOLD IN ONE OF THE LEAFLETS ALONG THE EDGE OF THE SEWING RING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6232393 ↗