Epic™ E200-29MRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 05415067033086), received between Jan 20, 2023 and Jul 27, 2026 — classified as 2 deaths, 18 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (7 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  (b)(6) - SH Device Registry, Patient Site ID: (b)(6). It was reported that on (b)(6) 2026, a 29mm Epic Mitral Plus valve was chosen for redo-surgical mitral valve. On (b)(6) 2026, the patient returned to the operating room due to mediastinitis.

  Patient problems: Inflammation

  MAUDE report 50019286 ↗
• MalfunctionJul 20, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25880897 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  CRD_(B)(4) - SH DEVICE REGISTRY, PATIENT SITE ID: (B)(4). IT WAS REPORTED THAT ON (B)(6) 2026 THAT A 29MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR IMPLANT. POST-PROCEDURE, IT WAS REPORTED THAT ON (B)(6) 2026, PATIENT EXPERIENCED PERICARDIAL EFFUSION AND REQUIRED PERICARDIAL DRAINAGE. CARDIAC TAMPONADE WAS REPORTED.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 25635539 ↗
• InjuryJun 2, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 29MM EPIC PLUS MITRAL VALVE WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2026, THE VALVE EXPLANTED AND A NON-ABBOTT VALVE WAS IMPLANTED DUE TO THROMBUS. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25366134 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(4) SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON 08 APR 26, A 29MM EPIC PLUS MITRAL VALVE WAS IMPLANTED IN THE PATIENT. AFTER THE IMPLANT, THE PATIENT PRESENTED WITH DYSPNEA. A CHEST X-RAY SHOWED ELEVATION OF THE RIGHT HEMIDIAPHRAGM CONSISTENT WITH RIGHT HEMIDIAPHRAGMATIC PARESIS ( SECONDARY TO INJURY OF THE RIGHT PHRENIC NERVE DURING STERNAL RE-OPENING). A NON INVASIVE MECHANICAL VENTILATION (NIMV) WAS INITIATED WITH A GOOD RESPONSE.

  Patient problems: Dyspnea; Movement Disorder

  MAUDE report 25255388 ↗
• InjuryFeb 16, 2026Incomplete Coaptation; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6)2025, A 29MM EPIC PLUS MITRAL VALVE WAS IMPLANTED IN THE PATIENT. THE PATIENT STARTED TO HAVE SHORTNESS OF BREATH STARTING (B)(6)2025. THE ECHOCARDIOGRAM (ECHO) SHOWED THROMBOSIS WITH INCREASING MITRAL VALVE GRADIENTS. THE VALVE GOT EXPLANTED. THE EXPLANTED VALVE SHOWED CLEAR THROMBOSIS, IMMOBILE LEAFLETS. THERE WERE NO CALCIFICATIONS, PERFORATIONS/TEARS, OR VEGETATIONS WERE SEEN. THE PATH REPORT CONSISTENT WITH ACUTE AND CHRONIC THROMBUS. THE PATIENT HAD A PACEMAKER WAS IMPLANTED. THE PATIENT WAS REPORTED STABLE AND DISCHARGED.

  Patient problems: Dyspnea; Insufficient Information; Mitral Valve Stenosis; Thrombosis/Thrombus

  MAUDE report 24349420 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(4) - SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 29MM EPIC PLUS MITRAL VALVE WAS IMPLANTED IN THE PATIENT. AFTER THE PROCEDURE, THE PATIENT EXHIBITED LEFT SIDED HEMIPARESIS DURING THE RECOVERY PHASE. THE COMPUTERIZED TOMOGRAPHY (CT) SCAN UNREMARKABLE BUT A STROKE WAS DIAGNOSED DURING A NEUROLOGICAL CONSULTATION. THE PATIENT REQUIRED 26 DAYS OF HOSPITALIZATION, PHYSIOTHERAPY AND NEUROLOGICAL REHABILITATION WERE GIVEN TO PATIENT. THE HEMIPARESIS OF THE LEFT ARM AND LEG WAS STILL PRESENT AT THE DISCHARGE. ON (B)(6) 2025, A PERICARDIAL EFFUSION WAS DETECTED DURING ULTRASOUND AND A PERICARDIOCENTESIS WAS PERFORMED. THERE WAS BEGINNING SIGNS OF TAMPONADE. THE PHYSICIAN MENTIONED ABBOTT DEVICE CAUSED THE PERICARDIAL EFFUSION. AFTER THAT ATRIAL FLUTTER WAS NOTED AND A CARDIOVERSION WAS PERFORMED. THE PATIENT HAD A PLEURAL EFFUSION AND DIURETICS WAS GIVEN TO THE PATIENT. ON (B)(6) 2025, SOME MEDICATIONS WERE ADMINISTRATED TO THE PATIENT. THE PATIENT WAS REPORTED IN THE RECOVERY PHASE.

  Patient problems: Atrial Flutter; Cardiac Tamponade; Movement Disorder; Pericardial Effusion; Pleural Effusion; Stroke/CVA

  MAUDE report 24277788 ↗
• InjuryJan 16, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 25MM EPIC VALVE IMPLANTED THREE YEARS AGO. ON (B)(6) 2025, THE VALVE WAS REMOVED DUE TO A DEFECT AT THE LIGATION SITE AND A NEW 29MM EPIC VALVE WAS IMPLANTED. THE PATIENT WAS REPORTED STABLE AND RECOVERING.

  Patient problems: Insufficient Information

  MAUDE report 24092982 ↗
• MalfunctionDec 24, 2025Intravalvular regurgitation; Intravalvular regurgitation

  N/A

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23888070 ↗
• InjuryDec 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 29MM EPIC PLUS MITRAL VALVE WAS IMPLANTED IN THE PATIENT. ON AN UNKNOWN DATE IN (B)(6) 2025, THE PATIENT HAD A HARD TIME ON BREATHING. THE PHYSICIAN INFORMED THE VALVE WAS FAILING AND NEEDED TO HAVE ANOTHER SURGERY. ON (B)(6) 2025, A NEW 29MM EPIC PLUS MITRAL VALVE WAS IMPLANTED IN THE PATIENT. THE EXPLANTED VALVE WAS 2/3 CLOTTED. AFTER THE SURGERY, THE PATIENT WAS WOULD NEED TO TAKE A BLOOD THINNER FOR THE REST OF HER LIFE AND NEEDED AN PACEMAKER AS WELL.

  Patient problems: Dyspnea

  MAUDE report 23790880 ↗
• MalfunctionNov 21, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6)2025, A, 29MM EPIC PLUS MITRAL VALVE WAS IMPLANTED IN THE PATIENT. AFTER THE IMPLANT, THE PHYSICIAN NOTICED THAT THE VALVE WAS LEAKING (MODERATE CENTRAL REGURGITATION) BETWEEN TWO LEAFLETS. THE VALVE WAS LEAKING ALONG THE COAPTATION LINE CONFIRMED BY ECHOCARDIOGRAM (ECHO). THE VALVE WAS REMOVED AND REPLACED WITH A NEW 29MM EPIC PLUS MITRAL VALVE WHILE PATIENT ON BYPASS. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619642 ↗
• InjuryOct 31, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A 29MM EPIC PLUS MITRAL VALVE WAS IMPLANTED 18 MONTHS AGO. ON (B)(6) 2025, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND COMPUTED TOMOGRAPHY IMAGING SHOWED THROMBUS. ON (B)(6) 2025, THE VALVE GOT EXPLANTED AND A NEW NON-ABBOTT VALVE WAS IMPLANTED. THE PATIENT WAS REPORTED STABLE AND DOING WELL.

  Patient problems: Dyspnea; Thrombosis/Thrombus

  MAUDE report 23441564 ↗
• InjuryOct 20, 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), (B)(4). IT WAS REPORTED THAT ON (B)(6) 2025, A 29MM EPIC PLUS MITRAL VALVE WAS IMPLANTED IN THE PATIENT. AFTER CLOSING STERNOTOMY, EXCESSIVE BLEEDING WAS FOUND THROUGH THE DRAINAGE TUBES REQUIRING STERNAL RE-OPENING WITH ABUNDANT BLOOD, WITHOUT CLOTS. HEMOSTASIS WAS ACHIEVED BUT BLEEDING PERSISTED, SO THE PATIENT WAS LEFT WITH PACKING AT THE EXIT POINT OF THE CECUM (CEC). A TEAR WAS FOUND IN THE ROOF OF LEFT ATRIUM WHICH REQUIRES RE-ENTRY INTO CEC AND REPAIR. THE PATIENT REQUIRED BLOOD TRANSFUSION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 23337200 ↗
• InjuryJun 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2025, A 29MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, WHEN THE SURGEON TURNED THE CRIMPER TO "COMPRESS" IT, THE SUPPORT THREADS BROKE AND MADE THE PLACEMENT OF THE PROSTHESIS IMPOSSIBLE, BECAUSE IT HAD ALREADY ON ITS FINAL SIZE. A NEW 29MM EPIC PLUS MITRAL VALVE WAS CHOSEN AND COMPLETED THE PROCEDURE. THERE WAS SOME DELAY IN THE PLACEMENT OF THE PROSTHESIS, EXTENDED EXTRACORPOREAL CIRCULATION (ECC) TIME AND A MEDICATIONS SUCH AS PROTHROMBIN, PROCONVERTIN, STUART FACTOR, AND ANTIHEMOPHILIC FACTOR B (PPSB) AND FIBRINOGEN WERE ADMINISTRATED. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22364723 ↗
• MalfunctionMay 5, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 29MM EPIC VALVE WAS SELECTED FOR IMPLANT. AT THE BEGINNING OF THE THREADING PROCESS, THE VALVE HOLDER RELEASED EVEN THOUGH THE PRESS RELEASE BUTTON WAS NEVER PRESSED. THIS CAUSED THE VALVE TO FALL TO THE FLOOR AND BECOME UNUSABLE. A 31MM EPIC VALVE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, HOWEVER THERE WAS A DELAY ASSOCIATED WITH THE REPLACEMENT. THE PATIENT CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961361 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(6) - SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 29MM EPIC PLUS MITRAL VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. THE PATIENT WAS ADMINISTERED 50,000 IE OF HEPARIN FOR PROCEDURE. THE PATIENT HAD A MINIMUM ACTIVATED CLOTTING TIME(ACT) LEVEL OF 655 SECONDS AND A MAXIMUM ACT LEVEL GREATER THAN 1000 SECONDS. THERE WAS NO DIFFICULTY IMPLANTING THE VALVE, SUCH AS MULTIPLE MANIPULATIONS. POST PROCEDURE, IT'S NOTED THE PATIENT WAS ADMINISTERED AN UNKNOWN REVERSAL AGENT. ON (B)(6) 2025, IT WAS NOTED THAT THE PATIENT HAD A PERICARDIAL EFFUSION NOTED 18MM LATERAL TO THE RIGHT VENTRICLE AND ATRIUM AND 18-23MM LATERAL TO THE LEFT VENTRICLE. THE DECISION WAS MADE TO PERFORM A PERICARDIOCENTESIS. THERE WAS NO PERICARDIAL EFFUSION NOTED PRIOR TO PROCEDURE. THE PATIENT WAS NOT TAKING AN ANTICOAGULANT OR ANTIPLATELET MEDICATION PRIOR TO PROCEDURE. HOWEVER, IT'S NOTED THAT THE PATIENT WAS TAKING 3,000 IE OF CERTOPARIN, TWICE A DAY BEFORE THE PERICARDIAL EFFUSION WAS DISCOVERED. ON (B)(6) 2025, IT WAS NOTED THAT THE PERICARDIAL EFFUSION WAS CIRCULAR, 9MM LATERAL TO THE RIGHT VENTRICLE AND ATRIUM AND 10MM INFEROLATERAL AND 14MM ANTER

  Patient problems: Pericardial Effusion

  MAUDE report 21876838 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21703363 ↗
• InjuryFeb 20, 2025Intravalvular regurgitation; Intravalvular regurgitation

  ON (B)(6) 2025, A 29MM EPIC VALVE WAS IMPLANTED USING MINIMALLY INVASIVE MITRAL VALVE REPAIR OR REPLACEMENT (MICSMVR). POST-IMPLANTATION, MILD ECCENTRIC REGURGITATION WAS OBSERVED ORIGINATING FROM THE COMMISSURE OF ONE LEAFLET, SPANNING FROM THE 6 O'CLOCK TO 10 O'CLOCK DIRECTION. IN RESPONSE, THE HEART WAS TEMPORARILY HALTED, AND ADDITIONAL SUTURES WERE APPLIED TO ADDRESS THE ISSUE. WHILE MILD MITRAL REGURGITATION (MR) PERSISTED, THE CHEST WAS SUBSEQUENTLY CLOSED, AND THE OPERATION WAS COMPLETED. THE PROCEDURE WAS EXTENDED 20 MINUTES DUE TO RE-PUMPING. THE PATIENT REMAINS IN STABLE CONDITION.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 21423024 ↗
• DeathDec 5, 2024Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 27MM EPIC VALVE WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, SUTURES WERE PLACED ON THE MITRAL RING AND THE 27MM EPIC VALVE WAS PARACHUTED DOWN INTO THE ANNULUS AND THE SUTURES WERE TIED. LEFT ARTERIORRHAPHY WAS THEN PERFORMED FOLLOWED BY MANEUVERS TO REMOVE AIR, AND REMOVAL OF THE AORTIC CLAMP. THE FIRST ATTEMPT TO TAKE THE PATIENT OFF OF CARDIOPULMONARY BYPASS WAS HALTED DUE TO THE PATIENT GOING INTO CARDIAC ARREST. CUSTODIOL WAS ADMINISTERED AND THE PROSTHESIS WAS CHECKED. ECHOCARDIOGRAM REVEALED THAT ONE OF THE LEAFLETS SHOWED RESTRICTED MOBILITY, REDUCING THE FLOW OF BLOOD FROM THE ATRIUM TO THE LEFT VENTRICLE. ANOTHER ATTEMPT TO TAKE THE PATIENT OFF CARDIOPULMONARY BYPASS, BUT AGAIN WAS NOT POSSIBLE. CUSTODIOL WAS ADMINISTERED AGAIN AND THE VALVE WAS REPLACED WITH 29MM EPIC VALVE. THE SAME RESULT OCCURRED WHILE TRYING TO TAKE THE PATIENT OFF OF CARDIOPULMONARY BYPASS. THERE WAS POOR MOBILITY OF THE PROTHESIS LEAFLETS WITH BIVENTRICULAR DYSFUNCTION. A 40MM INTRA-AORTIC BALLOON PUMP WAS IMPLANTED IN THE LEFT FEMORAL ARTERY, ALL SUPPORTS WERE ADJUSTED, AND ANOTHER ATTEMPT TO COME OFF CARDIOPULMONARY BYPASS WAS MADE WITHOUT SUCCESS. THE P

  Patient problems: Cardiac Arrest; Heart Failure/Congestive Heart Failure

  MAUDE report 20857525 ↗
• MalfunctionNov 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON 24 OCTOBER 2024, A 29MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, WHILE SUTURING THE VALVE, THE PHYSICIAN FELT A RESISTANCE. THE VALVE WAS RETRIEVED AND THEY DECIDED TO REDUCE THE SIZE OF THE VALVE. THERE WAS NO TEAR WAS OBSERVED IN THE LEAFLETS AND SUTURE CUFF. A NEW 27MM EPIC PLUS MITRAL VALVE WAS CHOSEN AND COMPLETED THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20709392 ↗
• InjuryOct 1, 2024Incomplete Coaptation; Patient Device Interaction Problem; Device Stenosis; Incomplete Coaptation; Patient Device Interaction Problem; Device Stenosis

  N/A.

  Patient problems: Mitral Valve Stenosis; Thrombosis/Thrombus

  MAUDE report 20343861 ↗
• InjuryMay 1, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON 16 FEB. 2024, A 29MM EPIC PLUS MITRAL VALVE WAS IMPLANTED IN A PATIENT. ON (B)(6) 2024, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS OF THE MITRAL VALVE AND IT WAS NECESSARY TO USE AN ANTICOAGULANT TO TREAT THE PROBLEM. TRANSESOPHAGEAL ECHOCARDIOGRAM IN ADDITION TO THE TRANSTHORACIC EXAMINATION CARRIED OUT ON (B)(6) 2024 SHOWED ANOMALOUS MOVEMENT OF THE INTERVENTRICULAR SEPTUM. PRESERVED MYOCARDIAL CONTRACTILITY OF THE OTHER SEGMENTS OF THE LEFT VENTRICLE. PRESERVED BIVENTRICULAR SYSTOLIC FUNCTION. BIOLOGICAL PROSTHESIS IN MITRAL POSITION WITH THIN LEAFLETS, PRESERVED OPENING (AV = 2.1 CM²). DOPPLER DOES NOT SHOW REFLUX. MAXIMUM DG OF 15 MMHG, AVERAGE DG OF 5MMHG. A HETEROGENEOUS IMAGE IS OBSERVED, WITH ANECHOIC POINTS INSIDE IT AND SMALL MOBILE COMPONENTS ADHERED TO ITS SURFACE ADJACENT TO THE MEDIAL PROSTHETIC RING, EXTENDING FROM THE LEFT ATRIAL WALL TO THE LOWER PORTION OF THE INTERATRIAL SEPTUM, MEASURING 14X5MM. ANOTHER SLIGHTLY HETEROGENEOUS IMAGE CAN BE SEEN ON THE LATERAL PORTION OF THE PROSTHETIC RING, MEASURING 3.6X8MM. SUCH FINDINGS MAY CORRESPOND TO ABSCESS FORMATION. THE PATIENT IS STABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19221087 ↗
• MalfunctionApr 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2024, A 29MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, WHILE RATCHETING BRINGING THE LEAFLETS TOGETHER, IT WAS NOTED THAT THE HOLDER OF THE VALVE FELL APART WHEN THEY STARTED TO USE. THE VALVE WAS IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143992 ↗
• DeathMar 21, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, A 29MM EPIC PLUS MITRAL WAS IMPLANTED. AT THE END OF 2ND WEEK OF IMPLANTATION THE PATIENT EXPERIENCED FEVER AND WAS ADMITTED TO THE HOSPITAL. IT WAS FOUND THAT THE PATIENT HAD ENDOCARDITIS AND WAS LATER DIAGNOSED WITH SEPTIC EMBOLY IN BRAIN. THE PATIENT HAD NO HISTORY OF ENDOCARDITIS AND WAS IN STABLE CONDITION POST IMPLANT. IT WAS REPORTED THAT THE PATIENT PASSED AWAY IN ONE WEEK ON (B(6) 2023. THE CAUSE OF DEATH WAS ENDOCARDITIS, SEPSIS AND INTRACRANIAL BLEEDING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Endocarditis; Sepsis; Unspecified Infection

  MAUDE report 16587455 ↗
• InjuryMar 8, 2023Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2023, A 29MM EPIC PLUS VALVE WAS CHOSEN FOR IMPLANT. THE VALVE WAS IMPLANTED. AT THE END OF THE PROCEDURE A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS DONE, AND A MINOR LEAK WAS NOTICED BETWEEN THE TWO LEAFLETS, CLOSE TO THE COMMISSURE. THE SAME DAY, THE PATIENT RETURNED TO SURGERY DUE TO CARDIAC TAMPONADE. A SECOND TEE WAS PERFORMED AND REVEALED MINOR MITRAL PERIPROSTHETIC REGURGITATION. THE DECISION WAS MADE TO LEAVE THE VALVE IN PLACE AND MONITOR THE PATIENT. THE PATIENT WAS REPORTED AS RECOVERING.

  Patient problems: Cardiac Tamponade; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 16506628 ↗