MITRIS RESILIA Mitral Valve 11400M (REF 11400M25)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00690103205534), received between Jun 7, 2022 and Mar 16, 2026 — classified as 29 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (18 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 29 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2026Insufficient Device Problem Information

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEAR, 5 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 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 24608090 ↗
• InjuryJan 29, 2026Insufficient Device Problem Information

  EDWARDS RECEIVED INFORMATION THROUGH ITS IMPLANT PATIENT REGISTRY THAT A 25MM 11400M VALVE WAS EXPLANTED AFTER A DURATION OF ONE (1) YEAR AND FOUR (4) MONTHS DUE TO UNKNOWN REASON. ANOTHER SAME MODEL 25MM 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 24211537 ↗
• InjuryAug 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 25MM 11400M MITRAL VALVE, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 MONTHS, 11 DAYS DUE TO LEAFLET MOTION RESTRICTED, MODERATE LEAFLETS THICKENED, THROMBOSIS AND SEVERE MITRAL STENOSIS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11400M VALVE. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND CHEST PAIN AND WAS FOUND WITH MODERATE LEAFLETS THICKENING (HALT) WITH SEVERELY REDUCED LEAFLET MOTION, THROMBOSIS, SEVERE MITRAL STENOSIS. THE PATIENT UNDERWENT A REDO MVR. INTRAOPERATIVELY, THE VALVE WAS INSPECTED AND REMOVED. THERE WAS A SUBSTANTIAL AMOUNT OF THROMBUS OF THE VENTRICULAR ASPECT OF THE VALVE WHICH EXTENDED INTO THE VENTRICLE. A 27MM 11400M WAS IMPLANTED AND SECURED WITH COR-KNOT. TEE DEMONSTRATED WELL SEATED VALVE WITHOUT PERIVALVULAR LEAK. ON POD #6, THE PATIENT WAS DISCHARGED. 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

  Patient problems: Dyspnea

  MAUDE report 22869422 ↗
• InjuryAug 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  EDWARDS RECEIVED INFORMATION THROUGH ITS IMPLANT PATIENT REGISTRY THAT A 25MM 11400M VALVE WAS EXPLANTED AFTER A DURATION OF ONE (1) MONTH DUE TO UNKNOWN REASON. ANOTHER SAME MODEL 25MM 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 22829931 ↗
• InjuryAug 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  EDWARDS RECEIVED INFORMATION THROUGH ITS IMPLANT PATIENT REGISTRY THAT A 25MM 11400M VALVE WAS EXPLANTED AFTER A DURATION OF ONE (1) MONTH DUE TO UNKNOWN REASON. ANOTHER SAME MODEL 25MM 11400M VALVE WAS IMPLANTED IN REPLACEMENT. NO OTHER DETAILS WERE 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 22691537 ↗
• InjuryJul 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY THAT A 11400M 25MM MITRAL VALVE WAS EXPLANTED AND REPLACED WITH A 11400M 25MM ON POD #20 DUE TO UNKNOWN REASONS. THE PATIENT EXPIRED DUE TO UNKNOWN REASONS. 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 22661814 ↗
• InjuryJun 9, 2025Degraded; Patient-Device Incompatibility; Patient Device Interaction Problem; Thickening of Material; Degraded; Patient-Device Incompatibility; Patient Device Interaction Problem; Thickening of Material

  JAPAN REPORTED THAT A 25MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF TWO (2) YEARS, TWO (2) MONTHS DUE TO PANNUS, LEAFLET SCLEROSIS, REGURGITATION, AND STENOSIS. THE EXPLANTED VALVE WAS REPLACED WITH A NON-EDWARDS MECHANICAL VALVE WITH NO PATIENT ADVERSE EVENTS REPORTED. THE PATIENT STATUS IS UNKNOWN AT THIS TIME. PER THE REPORTED INFORMATION, THE PATIENT BEGAN EXPERIENCING SYMPTOMS APPROXIMATELY SEVEN (7) MONTHS PRIOR TO THE DEVICE EXPLANT. THE MOTION OF ONE LEAFLET WAS REPORTEDLY NOT WELL. THE SURGEON COMMENTED AS THE INTRAOPERATIVE FINDING AT EXPLANT THAT PANNUS FORMATION WAS OBSERVED, BUT LEAFLET SCLEROSIS WAS ALSO NOTED. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 22172447 ↗
• InjuryJun 1, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORD THAT A 25MM 11400M MITRAL VALVE IN MITRAL POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 10 MONTHS, 10 DAYS DUE TO REGURGITATION. PATIENT PRESENTED WITH PULMONARY EDEMA AND FLUID VOLUME OVERLOAD. TMVR WAS COMPLETED WITH A 26MM 9750TFX TRANSCATHETER VALVE. PER MEDICAL RECORDS, ECHO DEMONSTRATED MODERATE ANNULAR CALCIFICATION OF THE MITRAL VALVE WITH MODERATE REGURGITATION. SIGNIFICANT TRICUSPID REGURGITATION WAS ALSO NOTED. PATIENT UNDERWENT TMVR, WAS TRANSFERRED TO THE ICU, AND WAS DISCHARGED ON POD #13. 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

  Patient problems: Pulmonary Edema

  MAUDE report 22121108 ↗
• InjuryMay 5, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH AN 25MM 11400M MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF ONE (1) YEAR AND 10 MONTHS. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER 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: Dyspnea; Insufficient Information

  MAUDE report 21964593 ↗
• InjuryApr 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 11400M MITRIS VALVE IN MITRAL POSITION IS UNDER EVALUATION FOR A POSSIBLE VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 YEARS, 8 MONTHS AND 27 DAYS DUE TO MITRAL REGURGITATION. TMVR HAS NOT BEEN SCHEDULED.

  Patient problems: Insufficient Information

  MAUDE report 21918038 ↗
• InjuryMar 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 18 DAYS DUE TO UNKNOWN REASON. 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 21598570 ↗
• InjuryJan 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS, 2 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 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 21106020 ↗
• InjuryDec 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED A 25MM 11400M MITRAL VALVE IMPLANTED 10 MONTHS, WAS EXPLANTED DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH AN UNKNOWN DEVICE. 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 20844375 ↗
• InjuryOct 21, 2024Mechanical Jam; Mechanical Jam

  PER THE REPORT RECEIVED FROM SOUTH KOREA, A 11400M25 VALVE IMPLANTED IN THE MITRAL POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF FOUR (4) DAYS. THE IMPLANTATION WAS INITIALLY REPORTED AS SUCCESSFUL. INTRAOPERATIVELY, THE SURGEON DOUBLE CHECKED THE VALVE'S FUNCTION AND ALL THREE LEAFLETS OPEN AND CLOSE WELL DURING VISUAL INSPECTION. DURING IMMEDIATE INTRA-OPERATIVE ECHOCARDIOGRAPHY, THERE WAS SLIGHTLY HIGH PRESSURE DETECTED, AND THE VALVE MOTION APPEARED NORMAL. HOWEVER, OVER THE FOLLOWING FOUR (4) DAYS, GRADUAL ABNORMAL FUNCTION WAS DETECTED. ECHOCARDIOGRAPHY DIAGNOSED THAT TWO LEAFLETS OF THE VALVE HAD BECOME IMMOBILE AND THE MITRAL VALVE AREA WAS VERY NARROWED (PEAK GRADIENT 35MMHG / MEAN GRADIENT 20 MMHG AND MITRAL VALVE AREA (MVA) OF 1.0 CM2). CONSEQUENTLY, A DECISION WAS MADE TO EXPLANT THE 11400M25 VALVE AND PROCEED WITH REOPERATION. ACCORDING TO THE SCRUB NURSE PRESENT DURING THE EXPLANT, THERE WAS NO EVIDENCE OF SUTURE LOOPING. A 27MM NON-EDWARDS VALVE WAS IMPLANTED IN REPLACEMENT. THE PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY (POD) 16 AND WAS IN STABLE CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 20501302 ↗
• InjurySep 13, 2024Perivalvular Leak; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Perivalvular Leak; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 11400M 25MM MITRAL VALVE WAS EXPLANTED AT IMPLANT BECAUSE THE ANTEROLATERAL STENT POST POSSIBLY CAUSED A HOLE IN THE LEFT VENTRICULAR WALL, LEADING TO BLEEDING AT THE BASE OF THE LEFT ATRIUM. A NON-EDWARDS VALVE WAS IMPLANTED IN REPLACEMENT. AS REPORTED, SURGEON NOTED THE TISSUE QUALITY OF THE PATIENT WAS LESS THAN HE EXPECTED. POST-BYPASS ECHO AFTER COMING OFF CPB INITIALLY REVEALS PROBABLE SEVERE MR IN LARGE PVL WITH JET ORIGIN POSTERIOR TO THE SEWING RING EXTENDING TO AT LEAST 25% OF THE CIRCUMFERENCE OF THE BIOPROSTHESIS. BLEEDING WAS NOTED AT THE BASE OF THE LEFT ATRIUM AND THE 25MM 11400M MITRAL VALVE IS EXPLANTED. CONCOMITANTLY, THE PATIENT HAD UNDERWENT AVR WITH AN INSPIRIS VALVE. ECHO REPORT SHOWS AORTIC VALVE BIOPROSTHESIS WITH NO AR AND NORMAL LEAFLET MOTION/APPEARANCE. THE AORTIC VALVE HAD TO BE EXPLANTED AT IMPLANT FOR BETTER VISUALIZATION AND REPAIR OF THE BLEEDING. AFTER DIFFICULT REPAIR, THE SURGEON OPTED TO IMPLANT A NON-EDWARDS VALVE AS THE SURGEON FELT THE POSTS WERE SHORTER AND POTENTIALLY LESS TRAUMATIC.

  Patient problems: Cardiac Perforation

  MAUDE report 20217147 ↗
• InjuryJun 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY (IPR). 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. IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT THIS MITRIS RESILIA VALVE MODEL 11400M25 IMPLANTED IN THE MITRAL POSITION WAS EXPLANTED FROM A 62-YEAR-OLD PATIENT AFTER AN IMPLANT DURATION OF TWO (2) MONTHS AND SIXTEEN (16) DAYS FOR UNKNOWN REASON. A 29MM SURGICAL VALVE WAS IMPLANTED IN REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 19573117 ↗
• InjuryJun 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 25MM 11400 MITRAL VALVE WAS EXPLANTED AND REPLACED WITH A 27MM 11400M MITRAL VALVE AFTER AN IMPLANT DURATION OF FIVE (5) MONTHS, 20 DAYS DUE TO UNKNOWN REASON. 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 19538058 ↗
• InjuryMar 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 25MM 11400M MITRIS VALVE UNDERWENT A REDO MITRAL VALVE REPLACEMENT PROCEDURE AFTER AN IMPLANT DURATION OF EIGHT (8) DAYS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH ANOTHER 25MM 11400M MITRIS VALVE.

  Patient problems: Insufficient Information

  MAUDE report 18915018 ↗
• InjuryJan 16, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  FOLLOW-UP ECHO APPROXIMATELY 1 MONTH POST TREATMENT: THERE IS A 25MM BIOPROSTHESIS IN THE MITRAL POSITION WITH NORMAL MOTION AND ELEVATED TRANSVALVULAR GRADIENTS AND MEAN GRADIENT OF 8MMHG.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18522399 ↗
• InjuryJan 7, 2024Mechanical Jam; Insufficient Device Problem Information; Mechanical Jam; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY, AND MEDICAL RECORDS THAT A 25MM 11400M MITRAL VALVE IN THE MITRAL POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF SIXTEEN (16) DAYS DUE TO ONE LEAFLET WITH LIMITED MOTION, MITRAL VALVE INSUFFICIENCY AND STENOSIS. THE PATIENT BEING TREATED FOR HEART FAILURE PRIOR TO SURGERY. THE PATIENT WAS DISCHARGED HOME ON POD #7. PER MEDICAL RECORDS: THE PATIENT UNDERWENT REMOVAL OF THE THYMUS, ROBOTIC EXPLANT OF THE MECHANICAL VALVE AND PLACEMENT OF A 25MM 11400M VALVE IN THE MITRAL POSITION. THE 25MM 11400A DID NOT SIT WELL ALONG THE STRUT ANTERIORLY. THE VALVE WAS EXPLANTED AT IMPLANT AND ANOTHER 25MM 11400M WAS IMPLANTED. A SMALL PORTION OF THE SUB ANNULAR MEMBRANE WAS REMOVED ANTERIORLY AND POSTERIORLY. THE VALVE APPEARED TO COAPT WELL AND THE STRUTS WELL PLACED IN THE LV. POST CPB TEE SHOWED GOOD LV FUNCTION, BIOPROSTHETIC MITRAL VALVE WITH LEAFLET MOTION, MILD TO MODERATE MR AND MODERATE MS, MEAN GRADIENT 11-13 MMHG. THE PATIENT WAS RETURNED TO THE PCICU INTUBATED IN STABLE CONDITION. THE PATIENT'S CONDITION DETERIORATED WITH INCREASING MITRAL REGURGITATION. THE ON POD #16 THE PATIENT UNDERWENT REPLACEMENT OF THE MITRAL VALVE WITH A 25M

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

  MAUDE report 18461447 ↗
• InjuryDec 27, 2023Difficult to Open or Close; Mechanical Jam; Difficult to Open or Close; Mechanical Jam

  IT WAS LEARNED THROUGH MEDICAL RECORDS REVIEW THAT A 25MM 11400M MITRAL VALVE EXHIBITED IMMOBILE LEAFLETS AFTER AN IMPLANT DURATION OF FOUR DAYS. PER MEDICAL RECORDS, UNDERWENT REDO MVR. ON POD #3, TEE REVEALED LIKELY THROMBUS FORMATION ON THE PROSTHETIC MITRAL VALVE. ON POD #4, THE PATIENT WAS TAKEN TO THE OR FOR RAMP STUDY. TEE REVEALED THAT TWO OF THE LEAFLETS APPEARED IMMOBILE ON THE MITRAL PROSTHETIC VALVE, WHICH WERE FROZEN WITH ALMOST A NEW FUSION OF THE COMMISSURE. THEREFORE, AN ATTEMPT WAS MADE TO FREE THEM UP BY ACCESSING THE LEFT ATRIUM AND PASSING A WIRE INTO THE VENTRICLE. THE WIRE APPEARED TO FALL INTO THE FROZEN COMMISSURE AND OPENED IT UP AND THE VALVE BEGAN TO FUNCTION; THEREFORE, FURTHER MANIPULATION WAS ABANDONED. THE INITIAL INTENTION WAS TO PERFORM A BALLOON VALVULOPLASTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18400047 ↗
• InjuryDec 1, 2023Adverse 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 25MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 MONTHS, AND 15 DAYS DUE TO UNKNOWN REASONS. UNKNOWN WHAT 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: Endocarditis; Insufficient Information

  MAUDE report 18248928 ↗
• InjuryOct 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED A 25MM 11400M MITRAL VALVE WAS EXPLANTED ON POD# 2 DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH A 31MM 11400M MITRAL 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 18016038 ↗
• InjuryOct 25, 2023Perivalvular Leak; Perivalvular Leak

  IT WAS LEARNED THROUGH PATIENT SUPPORT CENTER FROM PATIENTS CARE ADVOCATE AND INVESTIGATION THAT POST IMPLANT OF A 25MM 11400M MITRAL VALVE THERE WAS PARAVALVULAR REGURGITANT JET AND ON POD #20, PERCUTANEOUS TRANSSEPTAL CLOSURE OF PVL WAS PERFORMED. PER MEDICAL RECORDS THE PATIENT PRESENTED WITH SEVERE AORTIC STENOSIS, HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY, AND CORONARY ARTERY DISEASE. HE UNDERWENT SCHEDULED CABG X 1 AND AVR. INTRAOPERATIVELY, THE NATIVE AORTIC VALVE WAS HEAVILY CALCIFIED AND EXTENSIVE DECALCIFICATION OF THE ANNULUS WAS REQUIRED. THERE WAS ALSO EXTENSIVE CALCIUM EXTENDING DOWN ONTO THE ANTERIOR LEAFLET OF THE NATIVE MITRAL VALVE, THIS WAS MODESTLY DECALCIFIED TO PERMIT PLACEMENT OF THE AORTIC VALVE SUTURES. SEPTUM WAS EXTRAORDINARILY HYPERTROPHIED AS EXPECTED AND SEPTAL MYECTOMY WAS PERFORMED, IATROGENIC VSD WAS IDENTIFIED AND REPAIRED WITH SUTURES. A 23MM AORTIC VALVE WAS IMPLANTED AND SECURED WITH CORKNOTS, VALVE WAS FOUND TO BE WELLSEATED WITHOUT CORONARY OBSTRUCTION. WHILE WEANING BYPASS TEE SHOWED FAIRLY SEVERE NATIVE MITRAL REGURGITATION DUE TO ANNULAR DISTORTION. THE PATIENT WAS PLACED BACK ON FULL BYPASS AND A 25MM 11400M VALVE WAS IMPLANTED. POST PROCEDU

  Patient problems: Cardiomyopathy

  MAUDE report 18003262 ↗
• InjuryJul 1, 2023Gradient Increase; Patient-Device Incompatibility; Gradient Increase; Patient-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 11400M MITRAL VALVE HAS BEEN PLACED UNDER EVALUATION/CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 3 MONTHS DUE TO INCREASED GRADIENT. THE PLAN IS TO FOLLOW UP WITH A MVIV CT. PER INFORMATION RECEIVED THE GRADIENT ON ECHO IS 9-10MMHG. THE GRADIENT HAS REMAINED AT 9-10MMHG SINCE IMPLANT. THE SURGEON MENTIONED THE 25MM 11400M WAS THE LARGEST VALVE THEY WERE ABLE TO IMPLANT AND THAT PPM IS A POSSIBILITY. BASED ON THE ECHO-BASED GRADIENTS AND THE UNCHANGED GRADIENTS, THIS DOES NOT MEET THE VARC3 DEFINITION OF STRUCTURAL VALVE DETERIORATION.

  Patient problems: Insufficient Information

  MAUDE report 17244356 ↗