Epic™ E200-33MRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 05415067033109), received between Mar 2, 2023 and Sep 25, 2026 — classified as 18 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  (b)(4) - SH Device Registry, Patient Site ID: (b)(6).It was reported that on (b)(6) 2026, a 33mm Epic Plus Mitral Valve was chosen for redo-surgical mitral valve replacement. Post-intervention, patient experienced pleural effusion, requiring a pleural tap on (b)(6) 2026, draining 700 mL of serous fluid, and received two units of red packed blood cells transfusion. Patient also developed subcutaneous emphysema post-intervention, subsequently, bilateral chest tubes were inserted on (b)(6) 2026. It was later reported on 31 May 2026 that patient experienced acute coronary syndrome in a constellation with non-ST elevation myocardial infarction (NSTEMI). Patient had elevated troponin levels. A coronary angiography performed on (b)(6) 2026 revealed no hemodynamically significant stenoses.

  Patient problems: Cardiac Enzyme Elevation; Myocardial Infarction; Pleural Effusion; Unspecified Tissue Injury

  MAUDE report 50897587 ↗
• InjurySep 25, 2026Patient-Device Incompatibility

  CRD_1032 - SH Device Registry, Patient Site ID: (b)(6), (b)(6).It was reported that on (b)(6) 2024, a 33mm Epic Plus Mitral Valve was chosen for implant. It was later reported on (b)(6) 2026, patient had recurrent valvular endocarditis. A decision was made to perform redo-surgical mitral valve replacement with a second 33mm Epic Plus Mitral Valve on (b)(6) 2026.

  Patient problems: Endocarditis

  MAUDE report 50897526 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  (b)(4) - SH Device Registry, Patient Site ID: (b)(6).It was reported that on (b)(6) 2026, a 33mm Epic Plus Mitral valve was chosen for implant. Post-procedure on (b)(6) 2026, a mild-moderate pericardial effusion was noted during post-operative ultrasound study. The patient's hospital stay was extended for continued monitoring, but no intervention or medical treatment was reported. It was also reported on (b)(6) 2026, serous-appearing fluid was observed draining from the sternotomy wound site. There was no sign of inflammation or elevated acute phase reactants. A wound culture was ordered and tested positive for proteus mirabilis. Antibiotics were subsequently initiated on (b)(6) 2026.

  Patient problems: Pericardial Effusion; Post Operative Wound Infection

  MAUDE report 50018482 ↗
• InjuryJul 13, 2026Adverse Event Without Identified Device or Use Problem

  (B)(4) DEVICE REGISTRY, PATIENT SITE ID: (B)(6) (R1011361401). IT WAS REPORTED THAT ON (B)(6) 2026, A 33MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR IMPLANT. POST-PROCEDURE, PATIENT EXPERIENCED BIVENTRICULAR PUMP FAILURE. EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS IMPLANTED, AND PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT. ECMO WAS EXPLANTED ON POST-OPERATIVE DAY (POD) 2 FOLLOWING HEMODYNAMIC STABILITY. ON (B)(6) 2026, PATIENT EXPERIENCED POST-OPERATIVE ATRIAL FIBRILLATION AND DELAYED RECOVERY FROM ANESTHESIA. COMPUTED TOMOGRAPHY SHOWED NO EVIDENCE OF ACUTE ISCHEMIA. ON (B)(6) 2026, PATIENT EXPERIENCED RIGHT-SIDED HEMATOTHORAX. PATIENT RECEIVED BLOOD TRANSFUSION ON (B)(6) 2026. REOPERATION FOR HEMATOMA EVACUATION WAS PERFORMED ON (B)(6) 2026.

  Patient problems: Atrial Fibrillation; Heart Failure/Congestive Heart Failure; Hematoma; Hemothorax

  MAUDE report 25799492 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  (B)(4) DEVICE REGISTRY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2026, A 33MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR IMPLANT. POST-PROCEDURE ON 27 FEBRUARY 2026, PATIENT EXPERIENCED AN ONSET OF ATRIAL FIBRILLATION. ANTIARRHYTHMIC MEDICATION WAS ADMINISTERED ON (B)(6) 2026, AND ELECTRICAL CARDIOVERSION THERAPY WAS PROVIDED ON (B)(6) 2026. PATIENT WAS INTERMITTENTLY RETURNED TO SINUS RHYTHM.

  Patient problems: Atrial Fibrillation

  MAUDE report 25682282 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  CRD_1032 - SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6), (B)(4). IT WAS REPORTED THAT ON (B)(6) 2026, A 23MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR IMPLANT. POST-PROCEDURE ON (B)(6) 2026, PATIENT EXPERIENCED LEFT PLEURAL EFFUSION. A DECISION WAS MADE TO PERFORM A SURGICAL PUNCTURE TO REMOVE FLUID ON (B)(6) 2026.

  Patient problems: Pleural Effusion

  MAUDE report 25682280 ↗
• MalfunctionApr 3, 2026Fracture

  IT WAS REPORTED THAT ON (B)(6) 2026, A 33MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR A 73-YEAR-OLD PATIENT TREATED FOR INFECTIVE STREPTOCOCCAL ENDOCARDITIS BY MITRAL VALVE REPLACEMENT. DURING THE OPERATION, ONE OF THE THREE WIRES THAT HOLD THE BIOLOGICAL VALVE ON THE BASE BROKE AND REMAINED ATTACHED TO THE VALVE. THE WIRE WAS REMOVED WITH PLIERS IN SEVERAL PIECES. THERE WAS NO ACTUAL PATIENT CONSEQUENCES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24782034 ↗
• InjuryMar 10, 2026Perivalvular Leak; Detachment of Device or Device Component

  CLINICAL INFORMATION: CRD_1032 - SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 33MM EPIC PLUS MITRAL VALVE WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2026, THE PATIENT PRESENTED WITH DYSPNEA AND A MAJOR PARAVALVULAR LEAK WAS NOTED DUE TO VALVE DETACHMENT FOR THE POSTERIOR MITRAL ANULUS. THE VALVE GOT REMOVED. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Dyspnea; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24562679 ↗
• MalfunctionFeb 27, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 33MM EPIC VALVE WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE SUTURE GOT CAUGHT AROUND CALCIUM. A NEW 31MM EPIC VALVE WAS CHOSEN AND COMPLETED THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469967 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(6) - SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6) (R973411601). IT WAS REPORTED THAT ON (B)(6) 2025, A 33MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR A PROCEDURE. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED VARIOUS FLUCTUATING CARDIAC ARRHYTHMIAS. THE PATIENT WAS UNDER CONTINUES MONITORING. THE PATIENT'S RHYTHM WAS CHANGING FROM ATRIAL FIBRILLATION, ATRIOVENTRICULAR (AV) NODAL REENTRANT TACHYCARDIA AND AV BLOCK-1. SOME MEDICATIONS WERE GIVEN. POST PROCEDURE, THE PATIENT HAD A BRONCHOPULMONARY INFECTION AND RISING INFLAMMATION LEVELS. THE PATIENT TREATED WITH ANTIBIOTICS. THE PATIENT HAD PLEURAL EFFUSION WITH PUNCTION AND MEDICATIONS WERE GIVEN. THE PATIENT HAD A SIGNIFICANTLY IMPAIRED LEFT VENTRICULAR FUNCTION. ON (B)(6) 2025, THE PATIENT HAD A PERICARDIAL EFFUSION AND MEDICATIONS GIVEN. ON (B)(6) 2026, THE PATIENT HAD SINUS RHYTHM WITH AV BLOCK AND MEDICATIONS GIVEN. A CARDIOVERSION WAS PERFORMED ON (B)(6) 2025. ON (B)(6) 2025, THE TRANSTHORACIC ECHOCARDIOGRAPHY (TOE) NOTED THE PATIENT HAVING EJECTION FRACTION (EF) 40 %, ON (B)(6) 2025, EF 25 %, ON (B)(6) 2026 ~ EF 35 % AND MEDICATIONS WERE GIVEN.

  Patient problems: Atrial Fibrillation; Heart Block; Heart Failure/Congestive Heart Failure; Pericardial Effusion; Pleural Effusion; Tachycardia

  MAUDE report 24298296 ↗
• InjuryDec 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  N/A.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23871927 ↗
• InjuryDec 4, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) A 33MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR A PROCEDURE. AFTER IMPLANT, AT DE-CLAMPING, TRANSESOPHAGEAL ECHOCARDIOGRAPHY REVEALED A MODERATE-TO-SEVERE INTRA-PROSTHETIC REGURGITATION CONSISTENT WITH BIO PROSTHESIS DYSFUNCTION. THE VALVE WAS EXPLANTED AND NEW 33MM EPIC PLUS MITRAL VALVE WAS IMPLANTED. DUE TO THIS RESULTING IN A PROLONGED PROCEDURE TIME AND CONSEQUENTLY INCREASED RISK FOR THE PATIENT. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23716542 ↗
• MalfunctionNov 11, 2025Incomplete Coaptation; Material Split, Cut or Torn; Incomplete Coaptation; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2025, A 33MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR A MITRAL VALVE REPLACEMENT (MVR) PROCEDURE. DURING PROCEDURE, THE PHYSICIAN OPENED AND IMPLANTED THE VALVE AND TOOK THE HOLDER OFF THE VALVE TO TEST IT AND NOTICED A LEAFLET WAS TETHERED. THEY TESTED IT AND IT WOULD COAPT PROPERLY. THE VALVE WAS REMOVED AND A NEW 33MM EPIC PLUS MITRAL VALVE WAS SUCCESSFULLY IMPLANTED. THERE WAS ADDITIONAL 30 MINUTES TO CROSS CLAMP AND BYPASS TIME. THE PATIENT WAS REPORTED RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526058 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(6), PATIENT SITE ID: (B)(6) (B)(4). IT WAS REPORTED THAT ON (B)(6) 2025, A 33MM EPIC PLUS MITRAL VALVE WAS IMPLANTED IN THE PATIENT. IMMEDIATELY AFTER THE PROCEDURE, THE PATIENT DEVELOPED A THIRD-DEGREE ATRIOVENTRICULAR BLOCK (AV) ON (B)(6) 2025, A PERMANENT PACEMAKER WAS IMPLANTED.

  Patient problems: Heart Block

  MAUDE report 23439210 ↗
• InjuryJun 13, 2025Product Quality Problem; Intravalvular regurgitation; Product Quality Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 33MM EPIC PLUS MITRAL VALVE WAS IMPLANTED. FOLLOWING THE IMPLANT, THE PATIENT EXPERIENCED SEVERE MI. THE PHYSICIAN DISCOVERED THAT ONE OF THE LEAFLETS WAS LARGER/LONGER THAN THE OTHER TWO. THE PHYSICIAN WAS ABLE TO FIX THE ISSUE WITH A 6.0 SUTURE. THEY DON'T BELIEVE THE PATIENT OR USER EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. THE PATIENT IS STABLE.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 22206149 ↗
• MalfunctionMay 5, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 33MM EPIC PLUS MITRAL VALVE WAS SELECTED FOR IMPLANT. DURING PROCEDURE, ONCE THE DEVICE WAS PLACED, A WATER TEST WAS PERFORMED AND SHOWED THAT ONE OF THE LEAFLETS HAD A FOLD IN AND WASN'T ABLE TO OPEN. THE VALVE WAS REPLACED WITH ANOTHER 33MM EPIC PLUS MITRAL VALVE. THE PHYSICIAN DOESN'T BELIEVE THE PATIENT OR USER EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21962554 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(4) SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6), (R901134801). IT WAS REPORTED THAT ON (B)(6) 2024, A 33MM EPIC PLUS MITRAL VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. THERE WAS NO DIFFICULTY EXPERIENCED IMPLANTING THE 33MM EPIC PLUS MITRAL VALVE. ON (B)(6) 2024, IT WAS NOTED VIA ELECTROCARDIOGRAM THAT THE PATIENT DEVELOPED AN ONSET OF TACHYCARDIA WITH ATRIAL FIBRILLATION WHILE IN REHABILITATION. THE DECISION WAS MADE TO HOSPITALIZE THE PATIENT AND START AN AMIODARONE THERAPY. THE CAUSE OF THE PATIENT'S ATRIAL FIBRILLATION IS ATTRIBUTED TO THE IMPLANT PROCEDURE. THERE IS NO ALLEGATION OF MALFUNCTION AGAINST THE ABBOTT DEVICE OR PROCEDURE. THE PATIENT RECOVERED AT THE TIME OF REPORT.

  Patient problems: Atrial Fibrillation; Tachycardia

  MAUDE report 21663949 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: CRD_1032 - SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024, A 33MM EPIC PLUS MITRAL VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. PRIOR TO PROCEDURE IT'S NOTED THAT PATIENT WAS TAKING ACETYLSALICYLIC ACID. THE PATIENT WAS ADMINISTERED 40,000 IE OF HEPARIN FOR PROCEDURE. THE PATIENT HAD A MINIMUM ACTIVATED CLOTTING TIME (ACT) LEVEL OF 158 SECONDS AND A MAXIMUM ACT LEVEL OF 576 SECONDS. THERE WAS NO DIFFICULTY IMPLANTING THE DEVICE, SUCH AS MULTIPLE MANIPULATIONS. THE PATIENT WAS ADMINISTERED 350 MG OF PROTAMINE. ON (B)(6) 2024, IT WAS NOTED VIA ECHOCARDIOGRAM THAT THE PATIENT DEVELOPED AN 8MM ANTEROLATERAL PERICARDIAL EFFUSION. NO CARDIAC TAMPONADE WAS PRESENT. IT'S NOTED THAT THE PATIENT WAS ON 3000 IE OF MONO-EMBOLEX AT THE TIME THE PERICARDIAL EFFUSION WAS DISCOVERED. THERE WAS NO INTERVENTION PERFORMED OR PLANNED. THERE IS NO ALLEGATION OF MALFUNCTION AGAINST THE ABBOTT DEVICE OR PROCEDURE. THE PATIENT WAS DISCHARGED AT THE TIME OF REPORT.

  Patient problems: Pericardial Effusion

  MAUDE report 21625846 ↗
• InjuryNov 25, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 33MM EPIC PLUS MITRA VALVE WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2024, THE DEVICE WAS FAILING NOTED WITH VALVE THROMBOSIS, LEAFLET WAS NOT WITHIN THE RANGE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20774615 ↗
• MalfunctionMay 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6)2024, AN EPIC PLUS MITRAL VALVE WAS CHOSEN FOR IMPLANT. DURING PROCEDURE, THE VALVE WAS IMPLANTED, AND THE PHYSICIAN TRIED TO REMOVE THE PLASTIC HOLDER ATTACHED TO THE VALVE. WHILE PULLING ON THE KNOB ON TOP OF THE HOLDER, IT DISASSEMBLED INTO MULTIPLE PIECES. IT WAS ALSO NOTED THAT THERE WAS MORE RESISTANCE WITH THE EPIC PLUS MITRAL VALVE AFTER IT WAS CHANGED FROM THREE SUTURE CUTS TO ONE SUTURE CUT. ALL OF THE PIECES OF THE HOLDER WERE RETRIEVED. THERE WERE NO ADVERSE PATIENT EFFECTS. THE PATIENT STATUS WAS RECOVERING AND STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19265771 ↗
• InjuryMay 3, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 33MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR A PROCEDURE. THE VALVE WAS IMPLANTED. ON (B)(6) 2024, THE PATIENT WAS SYMPTOMATIC AND TRANSTHORACIC ECHOCARDIOGRAM (TTE) WITH COLOR DOPPLER SHOWED A THROMBOSIS IN THE PROTHESIS. THE INTERNATIONAL NORMALIZED RATIO (INR) AT THE TIME OF THROMBUS DETECTION WAS >2. AND THE INR MEASURED ON (B)(6) 2024 WAS 3.92. AN ANTICOAGULANT WAS USED TO TREAT THE EVENT. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Heart Failure/Congestive Heart Failure; Thrombosis/Thrombus

  MAUDE report 19242888 ↗
• MalfunctionAug 14, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT ON (B)(6) 2023, A 33MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR IMPLANT DURING A MITRAL VALVE REPLACEMENT. THE VALVE SIZE WAS CHOSEN AFTER EPIC PLUS HEART VALVE SIZER SET WAS USED TO SIZE THE MITRAL ANNULUS. AFTER THE VALVE WAS SUCCESSFULLY IMPLANTED, SALINE TESTING WAS CONDUCTED, AND IT WAS NOTED THAT THERE WAS A LEAK IN ONE OF THE LEAFLETS TOWARDS THE ANNULAR AREA. THE LEAK WAS BELIEVED TO BE CAUSED BY A NEEDLE PRICK AS THERE WAS A HOLE SEEN IN THE LEAFLET. THERE WERE NO INSTRUMENTS IN CONTACT WITH THE VALVE APART FROM THE VALVE HOLDER DURING THE PROCEDURE. THE VALVE WAS EXPLANTED AND REPLACED WITH A 31MM EPIC PLUS MITRAL VALVE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT STATUS WAS REPORTED AS STABLE AND WAS DISCHARGED. SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS A HOLE SEEN IN THE LEAFLET DURING SALINE TESTING DURING THE PROCEDURE. THERE WERE NO INSTRUMENTS IN CONTACT WITH THE VALVE APART FROM THE VALVE HOLDER DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17541596 ↗
• InjuryMay 25, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2023, A 33MM EPIC PLUS MITRAL WAS IMPLANT IN A PATIENT. DEVICE WAS EXPLANT DUE TO SEVERE MITRAL REGURGITATION WITH AN ECCENTRIC JET COMING FROM INSIDE THE RING OF THE VALVE SHOWING ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). UPON EXPLANT, THERE WAS A BIG TEAR AT THE BASE OF THE LEAFLETS AND AN UNKNOWN DEVICE WAS IMPLANTED. THE PATIENT IS STABLE.

  Patient problems: Insufficient Information

  MAUDE report 17007597 ↗
• InjuryMay 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2023, AN UNKNOWN MITRAL RING WAS CHOSEN FOR IMPLANT. IT WAS DETERMINED THAT THE UNKNOWN RING WAS NOT EFFECTIVE AND IT WAS DECIDED TO IMPLANT A 31MM EPIC PLUS MITRAL VALVE INSTEAD. HOWEVER, IT WAS OBSERVED THAT THE TEMPERATURE INDICATOR WAS ACTIVATED ON THE VALVE. THE PHYSICIAN DECIDED TO USE A NEW 33MM EPIC MITRAL VALVE BECAUSE THEY HAD ONLY THAT SIZE AVAILABLE. WHEN THEY TRIED TO USE THAT VALVE, THE HOLDER OF THE VALVE WAS DEFECTIVE AND IT WAS NOT STAYING ON THE INTRODUCER. THE VALVE FELL OFF THE HOLDER PRIOR TO PUTTING SUTURES THROUGH IT AND THEY ARE NOT ABLE TO PUSH THE VALVE INTO POSITION AS IT KEPT FALLING OFF. SO THE PHYSICIAN DECIDED TO REPLACE THE VALVE WITH A NEW 29MM EPIC VALVE. THE PATIENT ENDED UP WITH MUCH LONGER BYPASS AND CROSS CLAMP RUN AND THE PATIENT WAS HIGHLY UNSTABLE COMING OFF BYPASS AND REMAINED CRITICALLY ILL. A SMALLER SIZE NEW 29MM EPIC VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16904986 ↗
• MalfunctionMar 2, 2023Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2023, A 33MM EPIC PLUS WAS SELECTED FOR IMPLANTATION. DURING THE PROCEDURE, WHILE SUTURING THE DEVICE INTO PLACE, IT WAS NOTED THAT THE STENT POST HAD A DEFORMATION. THE DEVICE WAS REMOVED FROM PATIENT ANATOMY AND REPLACED WITH ANOTHER 33MM EPIC PLUS, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16474211 ↗