MITRIS RESILIA Mitral Valve 11400M (REF 11400M29)Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00690103205558), received between Jul 20, 2022 and Apr 16, 2026 — classified as 2 deaths, 47 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (26 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Patient-Device Incompatibility

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 29MM 11400M MITRAL VALVE WAS EXPLANTED AT IMPLANT DUE TO LEFT CORONARY ARTERY OBSTRUCTION. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 11400M VALVE. PER MEDICAL RECORDS, THE PATIENT UNDERWENT 3RD TIME REDO MITRAL VALVE EXPLANT OF PRIOR NON-EDWARDS TRANSCATHETER VALVE. THERE WAS EXTENSIVE EROSION INTO ANNULUS FROM THE PRIOR NON-EDWARDS TRANSCATHETER VALVE WITH MALPOSITIONING IDENTIFIED. A 29MM 11400M MITRIS MITRAL VALVE WAS IMPLANTED AND TRICUSPID VALVE REPAIR WAS PERFORMED. UPON SEPARATING FROM CPB THERE WAS CONCERN ABOUT THE LEFT CIRCUMFLEX CORONARY ARTERY. CORONARY ANGIOGRAM WAS PERFORMED AND THE LEFT CIRCUMFLEX CORONARY ARTERY APPEARED TO BE COMPROMISED ADJACENT TO THE 11400M MITRAL VALVE PROSTHESIS. BYPASS WAS RESTARTED AND LEFT ATRIUM WAS REOPENED. THE 29MM 11400M VALVE WAS EXPLANTED AND A NEW 29MM 11400M VALVE WAS IMPLANTED. THE LEFT ATRIUM WAS REINFORCED IN SOME AREAS DUE TO THE DESTRUCTION OF THE PREVIOUS TRANSCATHETER VALVE. AN INTRA-AORTIC BALLOON PUMP (IABP) WAS INSERTED FOR BIVENTRICULAR FUNCTION AND THEN ECMO WAS PLACED FOR CARDIOVASCULAR AND PULMONARY SUPPORT. HE PATIENT TOLERATED

  Patient problems: Coronary obstruction/occlusion

  MAUDE report 24906143 ↗
• InjuryFeb 27, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 29MM 11400M MITRAL VALVE IN MITRAL POSITION WAS EXPLANTED AND REPLACED WITH ANOTHER 29MM 11400M MITRAL VALVE AFTER AN IMPLANT DURATION OF 1 YEAR, 1 MONTHS, AND 10 DAYS. REASON FOR REINTERVENTION WAS NOT PROVIDED. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT." THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 24472296 ↗
• InjuryFeb 2, 2026Device Dislodged or Dislocated; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 29MM 11400M MITRAL VALVE WAS EXPLANTED ON POD #1 DUE TO SUTURE DEHISCENCE AND MODERATE PVL. THIS VALVE WAS REPLACED WITH A 31MM 11400M VALVE. PER MEDICAL RECORDS, S/P MVR THE PATIENT HAD ONGOING BLEEDING AND RETURNED TO THE OR URGENTLY FOR EVACUATION OF HEMOTHORAX ON POD #1. TEE SURPRISINGLY IDENTIFIED AT LEAST MODERATE PVL WHICH WAS NOT PRESENT ON THE POST-OP FINDINGS THE DAY PRIOR. THE MITRAL VALVE HAD 2 SUTURES IN THE POSTERIOR LEAFLET AROUND AREA OF CALCIFICATION THAT HAD PULLED THROUGH. THE VALVE WAS REMOVED; POSTERIOR ANNULAR CALCIFICATION WAS FURTHER DEBRIDED WITH LARGE AREA OF MAC, AND MOST OF THE NATIVE POSTERIOR LEAFLET HAD TO BE EXCISED. A 31MM 11400M VALVE WAS IMPLANTED WITH PLEDGETED SUTURES ON THE VENTRICULAR SIDE AND SECURED WITH COR-KNOTS. THE VALVE WAS HEAVILY PRESSURE TESTED WITH NO PVL AND NORMAL LEAFLET COAPTATION. THE PATIENT CONTINUED TO HAVE ON GOING BLEEDING THROUGHOUT THE PROCEDURE AND WAS FOUND UNDERSURFACE OF THE AORTA CONSISTENT WITH EXIT OF THE AORTIC CANNULA. THIS WAS CONTROLLED WITH SEVERAL PLEDGETED SUTURES. HEMOSTASIS IMPROVED, VV-ECMO WAS PLACED FOR SUPPORT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24242842 ↗
• InjuryJan 14, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 11400M MITRAL VALVE DEVELOPED VALVE THROMBUS ON POD #3 WHILE ON ECMO. PER THE NURSE PRACTITIONER, THE THROMBUS WAS TREATED WITH TPA (IV THROMBOLYTIC). PER MEDICAL RECORDS, THERE WAS NO EVIDENCE OF VALVE THROMBUS/TPA. THE PATIENT UNDERWENT ROBOTIC MVR FOR FLAILED NATIVE LEAFLET/DEGENERATION WITH SEVERE MAC. A 29MM 11400M VALVE WAS IMPLANTED, POST PROCEDURE TEE DEMONSTRATED A GOOD FUNCTIONING VALVE AND NO PVL. HOWEVER, THERE WAS SEVERE RV DYSFUNCTION/CARDIOGENIC SHOCK, THE PATIENT WAS PLACED ON AV-ECMO AND TRANSFERRED TO THE CARDIAC SURGERY ICU IN STABLE CONDITION. ON POD #3, THE PATIENT DEVELOPED STROKE; PUNCTATE AGE-INDETERMINATE LACUNAR RIGHT INFARCT. CT SHOWED NO EVIDENCE OF ACUTE TRANSCORTICAL INFARCTION, HEMORRHAGE, OR MASS LESION. POD #5, THE PATIENT WAS TAKEN BACK TO THE OR FOR DECANNULATION OF ECMO AND TOLERATED THE PROCEDURE WELL WITHOUT COMPLICATIONS. THE PATIENT WAS DISCHARGED ON POD #15. 6 DAYS LATER, OUTPATIENT ECHO SHOWED MITRAL VALVE WITH A MEAN GRADIENT OF 10MMHG, THERE WAS NO MENTION OF PRIOR THROMBUS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24073879 ↗
• InjuryJan 9, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A 29MM 11400M MITRAL VALVE WAS EXPLANTED AT IMPLANT DUE TO LEFT VENTRICULAR RUPTURE CAUSED BY POSSIBLE CONTACT OF THE STENT POST WITH THE LEFT VENTRICLE. DURING A MITRAL VALVE REPLACEMENT PROCEDURE VIA RIGHT ANTERIOR THORACOTOMY, AFTER IMPLANTATION OF THE DEVICE, LEFT VENTRICULAR RUPTURE OCCURRED. THE RUPTURE WAS IDENTIFIED BEFORE DECANNULATION. DURING SURGERY, THE APPROACH WAS CONVERTED TO A MEDIAN STERNOTOMY FOR DEVICE EXCHANGE. AFTER THE DEVICE EXPLANT, LEFT VENTRICULAR RECONSTRUCTION WAS PERFORMED, AND A NON-EDWARDS MECHANICAL VALVE WAS IMPLANTED AS A REPLACEMENT. THE PATIENT OUTCOME WAS NOT PROVIDED. THE SURGEON COMMENTED THAT THE CAUSE OF THE EVENT WAS NOT CLEAR, BUT THERE WAS A POSSIBILITY THAT THE STENT POST CAME INTO CONTACT WITH THE LEFT VENTRICLE AND CONTRIBUTED TO THE RUPTURE; THEREFORE, A MECHANICAL VALVE WITH NO STENT POSTS WAS SELECTED AS THE REPLACEMENT DEVICE.

  Patient problems: Rupture

  MAUDE report 24030108 ↗
• InjuryJan 8, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 29MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEAR, 2 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 31MM 11400M VALVE. A 27MM 11500A AORTIC VALVE WAS IMPLANTED CONCOMITANTLY. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL 'CUSTOMER COMPLAINT'. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 24010589 ↗
• InjuryDec 8, 2025Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AND LEARNED BY RECORDS PROVIDED THAT PATIENT WITH A 29MM 11400M MITRAL VALVE WAS EXPLANTED AT IMPLANT DUE TO BLEEDING CAUSED BY AV GROOVE DISRUPTION. THE TEAR WAS FIXED WITH A PATCH, AND THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11400M VALVE. PER RECORDS PROVIDED, AFTER IMPLANTING THE 29MM MITRIS VALVE IT WAS DISCOVERED THAT THERE WAS A LARGE AMOUNT OF BRIGHT RED BLOOD POOLING FROM THE BOTTOM OF THE VALVE. AFTER CAREFUL EXAMINATION IT WAS REVEALED A FOCAL AV GROOVE DISRUPTION. THEREFORE, IT WAS DECIDED TO REMOVE THE VALVE, AND IT WAS NOTED THAT ONE OF THE ANNULAR STITCHES HAD PULLED THROUGH AND CREATED A FOCAL DEFECT IN THE POSTERIOR ATRIAL WALL NEAR P2. A 27MM 11400M VALVE WAS IMPLANTED IN REPLACEMENT. INTRAOPERATIVE TEE DEMONSTRATED A WELL SEATED VALVE WITH A MEAN TRANSVALVULAR GRADIENT OF 1 MMHG. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO ICU FOR FURTHER RECOVERY.

  Patient problems: Laceration(s); Rupture

  MAUDE report 23750964 ↗
• InjuryDec 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 29MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 11400M VALVE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL 'CUSTOMER COMPLAINT'. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 23719871 ↗
• InjuryNov 22, 2025Perivalvular Leak; Insufficient Device Problem Information; Perivalvular Leak; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORD THAT A 29MM 11400M MITRAL VALVE IN MITRAL POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 DAY DUE TO PVL AND THROMBUS. THE REPLACEMENT VALVE IS A 27MM 11400 MITRAL VALVE AND PATIENT WAS IN RECOVERY POST-OPERATIVE. INTRAOPERATIVELY DURING INITIAL PROCEDURE, A NON-EW VALVE WAS IMPLANTED AND HAD PVL. SURGEON NOTED TISSUES WERE SO FRIABLE THAT THEY WERE TEARING AS THE HEART FILLED WITH BLOOD AROUND THE SUTURE LINE AREAS. AN AV GROOVE TEAR WAS NOTED. THE NON-EW VALVE WAS EXPLANTED AND REPLACED WITH A SMALLER 29MM 11400M MITRAL VALVE FOLLOWING AV GROOVE TEAR REPAIR WITH PERICARDIAL PATCH. SURGEON NOTED STILL NEW PVL IN AREA OF REPAIR BUT WAS NOTED TO BE MILD TO MODERATE AND DECIDED NOT TO PREFORM FURTHER REPAIR DUE TO VERY FRIABLE TISSUES. THE PATIENT TRANSFERRED TO CVICU IN GUARDED CONDITION ON MULTIPLE VASOPRESSORS. ON POD#1, PATIENT SUFFERED CARDIAC ARREST REQUIRING PERIPHERAL VA ECMO C/B PERICARDIAL TAMPONADE. CARDIOLOGY PERFORMED PERICARDIOCENTESIS BUT DUE TO ACTIVE BLEEDING DESPITE REMOVAL OF A LITER OF FLUID, THE PERICARDIAL EFFUSION WORSENED. PATIENT RETURNED TO THE OR FOR RE-EXPLORATION OF CHEST. IN ADDITIO

  Patient problems: Cardiac Arrest; Insufficient Information

  MAUDE report 23626727 ↗
• InjuryAug 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 29MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 MONTH, 26 DAYS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH AN UNKNOWN VALVE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL 'CUSTOMER COMPLAINT'. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 22852267 ↗
• InjuryAug 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  EDWARDS RECEIVED INFORMATION THROUGH ITS IMPLANT PATIENT REGISTRY THAT A 29MM 11400M VALVE WAS EXPLANTED AFTER A DURATION OF ELEVEN (11) MONTHS DUE TO UNKNOWN REASON. A SMALLER SIZE SAME MODEL 27MM 11400M VALVE WAS IMPLANTED IN REPLACEMENT. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL 'CUSTOMER COMPLAINT'. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 22829448 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED A 29MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF TWO (2) MONTHS, 27 DAYS, DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH A 33MM 11400M MITRAL VALVE. PATIENT POST-OPERATIVE STATUS NOTED AS IN RECOVERY. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL 'CUSTOMER COMPLAINT'. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 22692758 ↗
• InjuryJul 22, 2025Calcified; Calcified

  IT WAS REPORTED AND LEARNED THROUGH MEDICAL RECORDS THAT A PATIENT WITH A 29MM 11400M MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 YEARS, 2 MONTHS DUE TO DEGENERATION WITH CALCIFIED LEAFLETS, RESTRICTED LEAFLET MOTION AND STENOSIS WITH MEAN GRADIENT OF 14 MMHG. THE TMVR WAS SUCCESSFULLY PERFORMED WITH A 29MM 9600TFX VALVE. THE PROCEDURE WENT WELL, AND THE PATIENT WAS TRANSFERRED TO THE CVU FOR RECOVERY. THE PATIENT IS DOING WELL.

  Patient problems: Insufficient Information

  MAUDE report 22572149 ↗
• InjuryJul 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 29MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 MONTHS DUE TO UNKNOWN REASON. THE VALVE WAS REPLACED WITH A 29MM 11400M VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22560656 ↗
• InjuryJul 8, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 11400M MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 YEARS, 1 MONTH DUE TO SEVERELY REDUCED LEAFLET MOTION WITH SEVERE STENOSIS. THE PATIENT PRESENTED WITH ACUTE ON CHRONIC HEART FAILURE. THE SURGICAL VALVE WAS FRACTURED WITH A 28MM TRUE BALLOON, THEN THE TMVR WAS SUCCESSFULLY PERFORMED WITH A 29MM 9755RSL VALVE. THE PATIENT WAS TAKEN TO CICU IN STABLE CONDITION POST PROCEDURE. ON POD # 11, THE PATIENT UNDERWENT ORTHOTOPIC HEART TRANSPLANT. PER MEDICAL RECORDS: PRE-OP ECHO SHOWED WELL-SEATED MITRAL VALVE WITH SEVERELY REDUCED LEAFLET MOTION LEADING TO SEVERE STENOSIS, MG 21MMHG. CTA - NO ABNORMAL LEAFLET THICKENING, THROMBUS OR VEGETATION.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22453371 ↗
• InjuryJun 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 11400M MITRAL VALVE, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEAR, 6 MONTHS DUE TO THROMBOSIS. THE EXPLANTED VALVE WAS REPLACED WITH ANOTHER 29MM 11400M VALVE. THE DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: Insufficient Information; Thrombosis/Thrombus

  MAUDE report 22289637 ↗
• InjuryJun 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 11400M MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF ONE (1) YEAR AND FOUR (4) MONTHS DUE UNKNOWN. THE PROCEDURE WAS PERFORMED WITH 29MM 9600TFX TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22164045 ↗
• InjuryMay 8, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 11400M VALVE, IMPLANTED IN MITRAL POSITION, IS UNDER EVALUATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 YEARS AND 11 MONTHS DUE TO UNKNOWN REASON.

  Patient problems: Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 21990408 ↗
• InjuryMay 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  PER RESPONSE RECEIVED, THIS VALVE MODEL 11400M29 REMAINED IMPLANTED. THE INFORMATION IN IPR SUGGESTING THIS VALVE WAS EXPLANTED WAS INCORRECT. BASED ON THE INFORMATION PROVIDED DOES NOT REASONABLY SUGGEST THERE WAS A MALFUNCTION OF THE EDWARDS DEVICE OR THAT THE USE OR IMPROPER USE OF THE DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY OR DEATH. ADDITIONALLY, THERE WAS NO ALLEGATION OF DEFICIENCIES RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS OR PERFORMANCE OF THIS EDWARDS DEVICE. THEREFORE, THIS EVENT DOES NOT MEET THE CRITERIA FOR A COMPLAINT AS THERE IS NO DEVICE INVOLVED IN THIS CASE.

  Patient problems: Insufficient Information

  MAUDE report 21950133 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 29MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 MONTHS, 5 DAYS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 31MM 11400M MITRIS RELISA VALVE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL 'CUSTOMER COMPLAINT'. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 21729047 ↗
• InjuryMar 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 29 MM 11400 M MITRAL VALVE IN MITRAL POSITION WAS EXPLANTED AND REPLACED WITH A 25 MM 11400 M MITRAL VALVE AFTER AN IMPLANT DURATION OF 9 MONTHS AND 6 DAYS. REASON FOR REINTERVENTION WAS NOT PROVIDED. REPORTEDLY, PATIENT WAS IN RECOVERY POST-OPERATIVE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 21720793 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A 11400M 29MM VALVE IN TRICUSPID POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 1 YEAR, 8 MONTHS DUE TO SEVERE REGURGITATION, MILD HALT, WITH MOTION RESTRICTION. THE PATIENT PRESENTED WITH WORSENING DYSPNEA, FATIGUE, AND LOWER EXTREMITY EDEMA. A 9755RSL 29MM WAS IMPLANTED SUCCESSFULLY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21708727 ↗
• InjuryMar 22, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 29MM 11400M MITRAL VALVE, IMPLANTED IN TRICUSPID POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 MONTHS, 19 DAYS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11400M MITRIS RELISA VALVE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL 'CUSTOMER COMPLAINT'. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 21671191 ↗
• InjuryMar 3, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 11400M MITRAL VALVE IS UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 YEARS, ONE MONTHS DUE TO REGURGITATION.

  Patient problems: Insufficient Information

  MAUDE report 21510005 ↗
• InjuryFeb 10, 2025Fluid/Blood Leak; Intravalvular regurgitation; Fluid/Blood Leak; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 11400M MITRIS VALVE WAS PLACED UNDER EVALUATION FOR VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF ONE (1) YEAR, EIGHT (8) MONTHS DUE TO MITRAL REGURGITATION.

  Patient problems: Insufficient Information

  MAUDE report 21351423 ↗