MITRIS RESILIA Mitral Valve 11400M (REF 11400M27)Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00690103205541), received between Mar 12, 2022 and Apr 27, 2026 — classified as 56 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (30 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 58 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 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 25006497 ↗
• InjuryApr 22, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT A 27MM 11400M MITRAL VALVE WAS EXPLANTED AT IMPLANT DUE TO FRAME DISTORTION CAUSED BY INTERFERENCE FROM THE PREVIOUSLY IMPLANTED TAV. ANOTHER 27MM 11400 MITRAL VALVE WAS IMPLANTED IN REPLACEMENT. PER MEDICAL RECORDS, THE PATIENT DEVELOPED MS UNDERWENT MIS-MVR. INTRAOPERATIVELY AFTER SECURING THE FIRST 27MM VALVE IN PLACE, THE SURGEON COULD SEE THAT THE FRAME WAS SOMEWHAT DISTORTED, MORE OVOID THAN CIRCULAR. THIS DISTORTION CAUSED SOME TENSION ON ONE OF THE LEAFLETS CAUSING A GAP BETWEEN THE ANTERIOR LATERAL LEAFLET AND THE OTHER 2 LEAFLETS. THERE WAS SIGNIFICANT TRANSVALVULAR REGURGITANT LEAK. DECISION WAS MADE TO CONVERT TO A STERNOTOMY APPROACH AND EXPLANT THE VALVE. THEN A NEW 27MM 11400M VALVE WAS IMPLANTED. AS THE LAST COR-KNOTS WERE BEING SECURED THE VALVE AGAIN TOOK A DISTORTED OVOID SHAPE - THE SAME DISTORTION OF THE LEAFLET AS SEEN PREVIOUSLY (1ST VALVE) OCCURRED. TO FIX THIS THE SURGEON RELEASED ONE OF THE SUTURES WITH ITS COR-KNOT. THE VALVE FRAME THEN BECAME MORE CIRCULAR AND THE GAP BETWEEN THE LEAFLETS DISAPPEARED. POST PROCEDURE TEE SHOWED EXCELLENT FUNCTION OF THE WELL-SEATED VALVE AND NO PVL OR TRANSVALVULAR REGURGITATION. THE PATIENT WAS TRANS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955920 ↗
• InjuryMar 30, 2026Device Stenosis

  IT WAS LEARNED THROUGH INVESTIGATION THAT A PATIENT WITH A 27MM 11400M MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 YEARS AND 7 MONTHS DUE TO SEVERE STENOSIS. THE PATIENT WAS PRESENTED WITH SHORTNESS OF BREATH. THE DEVICE USED WAS A 29MM SAPIEN RESILIA VALVE. ACCORDING TO THE MEDICAL RECORDS, AFTER TMVR WAS PERFORMED ON (B)(6) 2025 WITH ECMO. POSTOPERATIVELY, THE PATIENT ALSO HAD COMPLICATIONS SUCH ATRIAL FIBRILLATION, GIB, RENAL INFARCT AND PANCREATIC NECROSIS. THE PATIENT CONTINUED TO DETERIORATE AND WAS LATER LEARNED THAT THE PATIENT EXPIRED ON POD#27.

  Patient problems: Dyspnea

  MAUDE report 24737290 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 11400M MITRAL VALVE IMPLANTED IN THE TRICUSPID POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 MONTHS AND 23 DAYS 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: Endocarditis; Insufficient Information

  MAUDE report 24719898 ↗
• InjuryFeb 27, 2026Break; Patient Device Interaction Problem; Material Split, Cut or Torn

  EDWARDS RECEIVED INFORMATION THAT A 27MM 11400M MITRAL PERICARDIAL VALVE, IMPLANTED APPROXIMATELY FOUR (4) YEARS, WAS EXPLANTED DUE TO MITRAL REGURGITATION(MR). THE PATIENT PRESENTED WITH HEMOLYTIC ANEMIA AND CHANGES IN URINE COLOR AND SYMPTOMS OF ANEMIA. THE DEVICE WAS EXPLANTED AND REPLACED WITH A NON-EDWARDS VALVE, EPIC. UPON RE-DO MITRAL VALVE REPLACEMENT (MVR), PERFORATIONS WERE FOUND IN TWO PLACES ON THE VALVE LEAFLET. NO CALCIFICATION WAS FOUND. IT WAS THOUGHT THAT THE PERFORATIONS HAD CAUSED MR. THE PATIENT STATUS WAS REPORTED AS STABLE CONDITION.

  Patient problems: Anemia; Hemolysis; Hemolytic Anemia

  MAUDE report 24474893 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 27MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 MONTHS, 12 DAYS DUE TO ENDOCARDITIS (S. EPIDERMIS) WITH REGURGITATION. THE EXPLANTED VALVE WAS REPLACED WITH A 31MM 11400M VALVE. THE PATIENT WAS IN RECOVERY POST PROCEDURE. PER PATHOLOGY REPORT (MICROSCOPIC DESCRIPTION): THE PROSTATIC VALVE SECTIONS DEMONSTRATE BOTH ACUTE AND CHRONIC ENDOCARDITIS. CONCOMITANTLY THE PATIENT UNDERWENT TRICUSPID VALVE REPAIR WITH A 26MM 4200T.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 24339435 ↗
• InjuryNov 26, 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 AND INVESTIGATION THAT A PATIENT WITH A 27MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 10 MONTHS 16 DAYS, DUE TO ENDOCARDITIS (E. FAECALIS) WITH DEGENERATION, SEVERE AI. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11400M VALVE. PER MEDICAL RECORDS, THE PATIENT PRESENTED ON 10/20 WITH NAUSEA AND VOMITING AND WAS DIAGNOSED WITH ENDOCARDITIS WITH SEVERE MR WITH BLOOD CULTURES POSITIVE FOR ENTEROCOCCUS FAECALIS. THE PATIENT UNDERWENT REDO-MVR WITH 27MM 11400M VALVE, TV REPAIR WITH 32MM TRICUSPID RING. POSTOPERATIVE COMPLICATION INCLUDED DECLINES IN RENAL FUNCTION, RESPIRATORY FAILURE AND MALNUTRITION. THE PATIENT EXPIRED ON POD#44.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 23661038 ↗
• InjuryOct 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEAR, 8 MONTHS DUE TO UNKNOWN REASONS. 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 23440402 ↗
• InjuryOct 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 27MM 11400M MITRAL VALVE IN MITRAL POSITION WAS EXPLANTED AND REPLACED WITH ANOTHER 27MM 11400M MITRAL VALVE AFTER AN IMPLANT DURATION OF 7 MONTHS AND 6 DAYS DUE TO UNKNOWN REASONS. REPORTEDLY, THE PATIENT WAS IN RECOVERY POST PROCEDURE. 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 23343777 ↗
• InjuryAug 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 27MM 11400M MITRAL VALVE, IMPLANTED IN THE TRICUSPID POSITION, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED DEVICE WAS REPLACED WITH A 27MM 11400M MITRAL VALVE. THE PATIENT WAS IN RECOVERY POST PROCEDURE. 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 22873573 ↗
• InjuryAug 19, 2025Calcified; Patient Device Interaction Problem; Calcified; Patient Device Interaction Problem

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 27MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF (B)(6) DUE TO EXTENSIVE CALCIFICATION, MODERATE PANNUS, RESTRICTED LEAFLETS, AND SEVERE STENOSIS. PRODUCT EVAL: CUSTOMER REPORT OF CALCIFICATION WAS CONFIRMED. X-RAY DEMONSTRATED MODERATE CALCIFICATION ON LEAFLET 2 AND THE REMAINDER OF LEAFLETS 1 AND 3. LEAFLET 3 HAD A TEAR APPROXIMATELY 12MM LONG AND CALCIFICATION WAS EVIDENT AT THE TEAR. HOST TISSUE OVERGROWTH WAS MODERATE ON THE STENT CIRCUMFERENCE ON BOTH ASPECTS AND ON THE REMAINDER OF LEAFLET 1 ON THE INFLOW ASPECT.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22841225 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 27MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF ONE (1) MONTH, AND ONE (1) DAY DUE TO ENDOCARDITIS (STAPHYLOCOCCUS LUGDENENSIS) WITH SEVERE STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE, FATIGUE, PALPITATION, AND DYSPNEA. THE EXPLANTED VALVE WAS REPLACED WITH ANOTHER 27MM 11400M MITRAL VALVE. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH FEVERS AND MALAISE. SHE RECENTLY HAD MVR DONE IN M(B)(6) 2025. THE PATIENT UNDERWENT REDO-MVR WITH A 27MM 11400M VALVE, TVR WITH 31MM MITRIS VALVE, REPAIR OF MITRAL ANNULAR ABSCESS, AND REMOVAL OF PPM. INTRAOPERATIVELY, THE MV WAS COMPLETELY OVERGROWN WITH THROMBUS OR VEGETATION. POST BYPASS TEE SHOWED NEW MV AND TV VALVE WERE WELL SEATED WITH NO PVL.

  Patient problems: Endocarditis

  MAUDE report 22627896 ↗
• InjuryJul 21, 2025Degraded; Perivalvular Leak; Degraded; Perivalvular Leak

  IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY THAT A 11400M 27MM VALVE IN MITRAL POSITION IS UNDER EVALUATION FOR POSSIBLE VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 YEARS, 9 MONTHS DUE TO DEGENERATION WITH SEVERE STENOSIS AND PVL. THE PATIENT PRESENTED WITH DYSPNEA. PER MEDICAL RECORDS, PATIENT UNDERWENT TAVR OF NATIVE AV WITH A 9755RSL 26MM TRANSCATHETER VALVE. MV IS STILL UNDER EVALUATION. 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

  MAUDE report 22555402 ↗
• InjuryJul 14, 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 27MM 11400M WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEAR AND 7 MONTHS DUE TO UNKNOWN REASON. THE VALVE WAS REPLACED WITH A 25MM 11400M VALVE,

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 22500813 ↗
• InjuryJul 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  EDWARDS RECEIVED INFORMATION THROUGH ITS IMPLANT PATIENT REGISTRY THAT A 27MM 11400M VALVE WAS EXPLANTED AFTER A DURATION OF FIVE (5) MONTHS DUE TO UNKNOWN REASON. ANOTHER 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 22483822 ↗
• InjuryMay 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 11400M MITRAL VALVE, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEAR, 9 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH ANOTHER 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 22106654 ↗
• InjuryMay 6, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED AND LEARNED FROM MEDICAL RECORDS, THAT A 27MM 11400M MITRIS RESILA MITRAL VALVE IN TRICUSPID POSITION WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 YEARS, 1 MONTH DUE TO MODERATE TO SEVERE REGURGITATION AND SIGNIFICANT STENOSIS. A 26MM SAPIEN 3 ULTRA RESILIA TRANSCATHETER VALVE WAS IMPLANTED. PER MEDICAL RECORDS THE PATIENT PRESENTED WITH DOE, FATIGUE. TEE DEMONSTRATED MODERATE TO SEVERE TRICUSPID REGURGITATION AND THERE WAS SIGNIFICANT TRICUSPID STENOSIS. THE PATIENT UNDERWENT TAVR IN WHICH A 26MM SAPIEN 3 ULTRA RESILIA TRANSCATHETER VALVE WAS DEPLOYED SMOOTHLY INTO THE FORAMEN OF THE 27MM 11400M MITRITS RESILIA. THE HEMODYNAMICS WERE GOOD; TEE SHOWED A WIDE-OPEN VALVE WITH A MEAN GRADIENT 2 MMHG. THERE WERE NO OTHER ISSUES. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED BACK TO THE ROOM IN GOOD CONDITION.

  Patient problems: Dyspnea

  MAUDE report 21970989 ↗
• InjuryMay 5, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 11400M MITRAL VALVE IS UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 YEARS, 5 MONTHS DUE TO SEVERE STENOSIS. PATIENT WAS ASYMPTOMATIC. THIS IS A 52-YEAR-OLD FEMALE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965198 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS THAT A PATIENT WITH A 27MM 11400M MITRAL VALVE, IMPLANTED IN THE TRICUSPID POSITION, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEAR AND 9 MONTHS DUE TO LEAFLET ENTRAPMENT BY HOST TISSUE OVERGROWTH (PANNUS), CAUSING SEVERE REGURGITATION AND MODERATE STENOSIS. THE PATIENT PRESENTED WITH SYMPTOMS OF CLASS 3-4 NYHA HEART FAILURE. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 7300TFX MAGNA EASE MITRAL VALVE. THE PATIENT WAS IN STABLE CONDITION AND WAS DISCHARGED ON POD#13. PER MEDICAL RECORDS, THE PATIENT HAD A HISTORY OF TVR AND UNDERWENT AN UNEVENTFUL POSTOPERATIVE COURSE AND DEVELOPED THROMBOSIS DESPITE COUMADIN. THE PATIENT'S VALVE DYSFUNCTION CONTINUED, LEADING TO CONGESTIVE HEART FAILURE SYMPTOMS. TEE DEMONSTRATED THICKENED AND RETRACTED LEAFLETS WITH REDUCED MOTION AND NON-COAPTATION, WHICH LED TO SEVERE CENTRAL TRICUSPID REGURGITATION AND MODERATE TRICUSPID STENOSIS. THE PATIENT UNDERWENT A REDO STERNOTOMY, AND THE 27MM 11400M MITRIS MITRAL VALVE IN THE TRICUSPID POSITION WAS EXPLANTED. INTRA-OPERATIVELY, THERE APPEARED TO BE SIGNIFICANT TISSUE OVERGROWTH (PANNUS) OVER THE ENTIRE VALVE, AND THAT BECAUSE OF

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 21925342 ↗
• InjuryApr 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 11400M MITRAL VALVE, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEAR, 1 MONTH DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH ANOTHER 25MM 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 21867521 ↗
• InjuryApr 4, 2025Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 11400M MITRIS VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF ONE (1) YEAR, THREE (3) MONTHS DUE TO SEVERE MITRAL STENOSIS, CALCIFICATION, DEGENERATION, AND FROZEN LEAFLETS. THE PATIENT INITIALLY PRESENTED WITH HEART FAILURE AND CARDIOGENIC SHOCK. THE TMVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. THE PATIENT DID WELL AND WAS DISCHARGED POST PROCEDURE.

  Patient problems: Cardiogenic Shock; Heart Failure/Congestive Heart Failure

  MAUDE report 21776450 ↗
• InjuryMar 25, 2025Calcified; Thickening of Material; Device Stenosis; Calcified; Thickening of Material; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH AN 11400M MITRIS VALVE OF UNSPECIFIED SIZE WAS PLACED UNDER EVALUATION FOR REDO MITRAL VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF TWO (2) MONTHS DUE TO MITRAL STENOSIS. PATIENT RETURNED AFTER APPROXIMATELY ONE (1) MONTH POST-OP WHILE ON ELIQUIS AND WAS ADMITTED FOR HEPARIN DRIP AND INTERVENTION. PATIENT WAS PUT ON HEPARIN DRIP AND COUMADIN AND VALVE GRADIENT WAS REDUCED TO 9MMHG.

  Patient problems: Insufficient Information

  MAUDE report 21692239 ↗
• InjuryMar 10, 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 27MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 MONTHS, 12 DAYS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 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 21561223 ↗
• InjuryFeb 24, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A 11400M 27MM VALVE IN TRICUSPID POSITION WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 YEARS, 4 MONTHS DUE TO STENOSIS. A 9755RSL 29MM TRANSCATHETER VALVE WAS IMPLANTED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 21447936 ↗
• InjuryJan 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 11400M VALVE. THE PATIENT WAS TAKEN TO RECOVERY POST PROCEDURE. PER IDC, THERE WAS NO DEVICE DEFICIENCY. 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 21286712 ↗