Epic™ E100-29M-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05414734055598), received between Jun 29, 2018 and Jul 1, 2024 — classified as 4 deaths, 10 injuries, 1 malfunction.

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

• InjuryJul 1, 2024Calcified; Material Deformation; Device Stenosis; Calcified; Material Deformation; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2021, A 29MM EPIC VALVE WAS IMPLANTED IN THE PATIENT. AFTER THE PROCEDURE, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND ECHOCARDIOGRAM SHOWED A GRADIENT OF 10MM. THE VALVE WAS CALCIFIED WITH SOME LEAFLET DEFORMITY. THE VALVE WAS EXPLANTED AND A NEW NON- ABBOTT VALVE WAS IMPLANTED. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Dyspnea; Mitral Valve Stenosis

  MAUDE report 19651834 ↗
• InjuryJan 7, 2022Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED ON (B)(6) 2021, A 29MM EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM WAS IMPLANTED. POST IMPLANT AN ECHOCARDIOGRAM WAS PERFORMED AND NOTED THAT THE LEAFLETS WOULD NOT OPEN FULLY. THE VALVE WAS EXPLANTED AND REPLACED WITH A NEW 29MM EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM. THE PATIENT WAS ON BYPASS FOR THE PROLONGED PERIOD OF TIME AND DUE TO RELIGION THE PATIENT WAS NOT ABLE TO RECEIVED BLOOD PRODUCTS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND SINCE HAS BEEN DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13196846 ↗
• InjuryJun 24, 2021Backflow; Obstruction of Flow; Backflow; Obstruction of Flow

  IT WAS REPORTED THAT ON (B)(6) 2021, A 29MM EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM WAS SELECTED FOR IMPLANT. DURING THE IMPLANT PROCEDURE, THE SIZING WAS A LITTLE LARGE, BUT WAS SEATED WITHOUT TOO MUCH DIFFICULTY. THE VALVE COMPETENCE WAS CHECKED INTRAOPERATIVELY AND SHOWED A SMALL MODERATE LEAK, BUT APPEARED TO CLOSE, SO THE PATIENT WAS REMOVED OFF OF BYPASS. ON ECHO MODERATE ECCENTRIC CENTRAL LEAK ACROSS THE VALVE OBSERVED AND WHAT APPEARED TO BE ONE LEAFLET THAT WAS CONSTRAINED AND NOT OPENING COMPLETELY. THE PATIENT WAS PLACED BACK ON BYPASS AND HAD THE VALVE REMOVED AND REPLACED WITH A 27MM EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM. THE SECOND IMPLANT WENT SMOOTHLY AND THE POST OP ECHO WAS PERFECT WITH NO LEAK OBSERVED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT, BUT THE PROCEDURE WAS EXTENDED DUE TO THE DEVICE REPLACEMENT. THE PATIENT IS DOING WELL AND IS RECOVERING. THE CAUSE OF THE LEAK ISN'T CLEAR BUT THE PHYSICIAN SPECULATES THAT THE VALVE MAY HAVE BEEN SLIGHTLY OVERSIZED AND THE CALCIUM ON THE ANNULUS MAY HAVE CAUSED SOME VALVE DEFORMITY WHICH COULD HAVE CREATED THE LEAK. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 12063943 ↗
• InjuryFeb 4, 2021Backflow; Perivalvular Leak; Backflow; Perivalvular Leak

  ON (B)(6) 2021, A 29MM EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM WAS IMPLANTED. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS OBTAINED WHILE IN THE OPERATING ROOM, WHICH SHOWED MODERATE CENTRAL AND PERIVALVULAR LEAK. THE EPIC VALVE WAS EXPLANTED AND A NEW 29MM EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11278732 ↗
• InjuryJun 2, 2020Perivalvular Leak; Biocompatibility; Perivalvular Leak; Biocompatibility

  ON (B)(6) 2019, A 29MM EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM WAS IMPLANTED. A FEW MONTHS AFTER IMPLANTED AN ECHOCARDIOGRAM WAS PERFORMED AND A PARAVALVULAR LEAK WAS NOTED AND POSSIBLE ENDOCARDITIS. THE VALVE WAS EXPLANTED ON (B)(6) 2020, AND WAS REPLACED WITH ANOTHER 29MM EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM. THE PATIENT WAS REPORTED IN STABLE CONDITION.

  Patient problems: Endocarditis; Urinary Tract Infection

  MAUDE report 10112794 ↗
• InjuryMay 15, 2020Biocompatibility; Biocompatibility

  THE PATIENT WAS REPORTED TO HAVE AN INFECTION RELATED TO THE MITRAL VALVE STATING, "CATH LAB REPORT AND ECHO RESULTS SHOWED MITRAL VEGETATION AND LARGE POSTERIOR ANNULAR ABSCESS." NO FURTHER PATIENT INFORMATION AVAILABLE.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 10061799 ↗
• InjuryMar 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2020, A 29MM EPIC VALVE WAS SELECTED FOR IMPLANT. IT WAS REPORTED THAT THE VALVE WAS "DEFECTIVE" AND EXCHANGED FOR A NEW 29MM EPIC VALVE. IT WAS REPORTED THAT THE VALVE WAS IMPLANTED AND THEN REMOVED. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER IS NOT AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9900903 ↗
• InjuryMar 18, 2020Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 2019, A 23MM TRIFECTA GT VALVE WAS IMPLANTED IN AORTIC POSITION AND A 29MM EPIC VALVE WAS IMPLANTED IN THE MITRAL POSITION. ON AN UNKNOWN DATE THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND FATIGUE. ON (B)(6) 2020, THE TRIFECTA VALVE WAS EXPLANTED DUE TO 2 SMALL LEAFLET HOLES AND WAS REPLACED WITH A MEDTRONIC ULTRA VALVE. THE EPIC VALVE SEEMED TO BE OKAY BUT ON AN ECHOCARDIOGRAM IT WAS REPORTED TO HAVE POSTERIOR PROLAPSED LEAFLET AND IT WAS EXPLANTED AND EXCHANGED FOR A MOSAIC ANS VALVE. THE PATIENT WAS REPORTED TO BE STABLE CONDITION. MANUFACTURER REPORT NUMBER: 3001883144-2020-00025.

  Patient problems: Dyspnea; Fatigue

  MAUDE report 9851285 ↗
• DeathSep 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION RECEIVED FROM PATIENT DEVICE TRACKING NOTES THAT ON (B)(6) 2019, A 29MM EPIC MITRAL VALVE WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, THE PATIENT PASSED AWAY WHILE IN THE OPERATING ROOM. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Death

  MAUDE report 9010596 ↗
• DeathAug 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2017, A 29 MM EPIC STENTED PORCINE VALVE WAS SELECTED FOR IMPLANT. IT IS UNKNOWN IF THE VALVE WAS SUCCESSFULLY IMPLANTED. ON AN UNKNOWN DATE THE PATIENT EXPIRED OF UNKNOWN CAUSES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Death

  MAUDE report 8935370 ↗
• InjuryMay 24, 2019Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 2019, A 29MM EPIC VALVE WAS SELECTED FOR IMPLANT. DURING PROCEDURE PREPARATION, ONE OF THE LEAFLETS WAS OBSERVED TO BE FOLDED AND NOT COAPTING PROPERLY. THE PHYSICIAN PLACED SUTURES AND TESTED THE VALVE INSIDE OF THE PATIENT; HOWEVER, THE ISSUE OF COAPTATION PERSISTED. THE VALVE WAS REMOVED AND EXCHANGED FOR A 31MM EPIC VALVE. PER THE SITE, THERE WAS A CLINICALLY SIGNIFICANT EXTENSION IN PROCEDURE TIME. THE PATIENT IS REPORTED TO BE DISCHARGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8640919 ↗
• MalfunctionDec 18, 2018Material Puncture/Hole

  EPIC VALVE WAS OPENED AND PASSED TO SCRUB RN WHO RINSED WITH SALINE AND PASSED TO FIELD. ONE SUTURE NEEDLE PLACED IN VALVE WHEN DOCTOR REQUESTED NEW EPIC VALVE, SAME SIZE. PER DOCTOR, THERE WAS A "HOLE IN THE SKIRT". NOTIFIED ANOTHER STAFF MEMBER AND PACKAGED VALVE PER THEIR INSTRUCTIONS. NEEDLE STILL IN VALVE, VALVE IN SPECIMEN CUP AND DOUBLE BAGGED. PLACED IN LARGER BAG WITH ALL PACKAGING MATERIAL AND LABELED WITH BIOHAZARD STICKERS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8174992 ↗
• DeathDec 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018, A 29MM EPIC VALVE WAS SELECTED FOR IMPLANT IN THE MITRAL POSITION. ON (B)(6) 2018, ABBOTT WAS MADE AWARE FROM PATIENT DEVICE TRACKING THAT THE PATIENT EXPIRED DURING SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Death

  MAUDE report 8131110 ↗
• InjuryOct 11, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2015, A 29MM EPIC VALVE WAS IMPLANTED IN THE MITRAL POSITION. ON (B)(6) 2018, THE PATIENT PRESENTED WITH SYMPTOMS OF CHRONIC HEART FAILURE. ON (B)(6) 2018, THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER 29MM EPIC VALVE (SERIAL NUMBER UNKNOWN). UPON EXPLANT, ONE OF THE LEAFLETS WAS OBSERVED TO BE TORN. THE PATIENT IS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: Aortic Insufficiency

  MAUDE report 7955609 ↗
• DeathJun 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN (B)(6) 2018, A 29MM EPIC MITRAL HEART VALVE WAS CHOSEN FOR IMPLANT. WHEN THE VALVE WAS ATTEMPTED TO BE IMPLANTED, THE PHYSICIAN BELIEVES ONE OF THE STENT POSTS MAY HAVE CAUSED THE MYOCARDIUM TO TEAR AND DISSECT. THE VALVE WAS REPLACED DURING THE PROCEDURE WITH A CARBOMEDICS MECHANICAL VALVE. THE PATIENT IS REPORTED TO BE DECEASED. THE CIRCUMSTANCES SURROUNDING THE DEATH AND THE TIMING OF THE DEATH WERE NOT PROVIDED. ABBOTT¿S REPRESENTATIVE WAS UNABLE TO OBTAIN ANY ADDITIONAL INFORMATION.

  Patient problems: Cardiac Perforation; Death

  MAUDE report 7653037 ↗