MITRIS RESILIA Mitral Valve 11400M (REF 11400M33)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00690103205572), received between Nov 10, 2022 and Jun 4, 2026 — classified as 1 death, 25 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (19 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 26 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 33MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 MONTH DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 33MM 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 25398025 ↗
• InjuryJan 30, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 33MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED DEVICE WAS REPLACED WITH A 33MM 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 24222934 ↗
• InjuryJan 30, 2026Patient-Device Incompatibility

  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 (IPR) THAT, DURING THE EXPLANT OF A MITRAL ANNULOPLASTY RING DUE TO DEHISCENCE AT THE A1/P1 REGION RESULTING IN SEVERE PARAVALVULAR REGURGITATION, SURGICAL RECONSTRUCTION OF THE ANNULUS WAS PERFORMED DUE TO THE POOR TISSUE QUALITY, FOLLOWED BY THE IMPLANTATION OF A 11400M33 VALVE. UPON COMPLETION OF THE PROCEDURE, DISTORTION OF THE AORTIC VALVE ANNULUS WAS OBSERVED, LEADING TO MODERATE-TO-SEVERE AORTIC REGURGITATION AND NECESSITATING AORTIC VALVE REPLACE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220518 ↗
• InjurySep 15, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT WITH A 33MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 DAYS DUE TO LVOT OBSTRUCTION WITH HIGH GRADIENTS. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 11400M VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE. PER MEDICAL RECORDS AND ADDITIONAL INFORMATION, THE PATIENT HAD HIGH LVOT GRADIENT AND LVOT OBSTRUCTION DUE TO SUBVALVULAR APPARATUS AND ANTERIOR LEAFLET OBSTRUCTION. TEE REVEALED LVOT OBSTRUCTION POSSIBLY RELATED TO A PAPILLARY HEAD NEAR THE AV ANNULUS. THE SURGEON EXPLANTED THE 33MM 11400M EXCISED THE ANTERIOR LEAFLET AND SUB VALVULAR APPARATUS AND IMPLANTED 29MM 11400M. THE INTRAOPERATIVE TEE SHOWED NO SIGNIFICANT LVOT OBSTRUCTION AND NO PERIVALVULAR LEAK.

  Patient problems: Obstruction/Occlusion

  MAUDE report 23058341 ↗
• InjuryMay 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH AN 33MM 11400M MITRAL VALVE, IMPLANTED IN THE TRICUSPID POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 MONTHS DUE TO UNKNOWN REASONS. THE PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22101656 ↗
• InjuryMay 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 33MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 MONTHS, 17 DAYS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 33MM 11400M VALVE. THE PATIENT WAS TRANSFERRED TO 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 22039661 ↗
• InjuryMay 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 33MM 11400M MITRAL VALVE HAS BEEN PLACED UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 YEARS, 4 MONTHS DUE TO UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 21995317 ↗
• InjuryMar 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 33MM 11400M MITRAL VALVE, IMPLANTED IN THE TRICUSPID POSITION, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEAR, 1 MONTH DUE TO UNKNOWN REASON. THE EXPLANTED DEVICE WAS REPLACED WITH A 31MM 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 21653581 ↗
• InjuryNov 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 33MM 11400M MITRIS VALVE UNDERWENT REDO MITRAL VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF 11 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 31MM 11400M MITRIS 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 20678921 ↗
• InjuryNov 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED A 33MM 11400M MITRAL VALVE WAS EXPLANTED AFTER IMPLANT DURATION OF FOUR (4) MONTHS, 16 DAYS, 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 20613747 ↗
• InjuryOct 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY THAT A 11400M 33MM MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 MONTHS 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 20546114 ↗
• InjuryOct 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 33MM 11400M MITRIS VALVE UNDERWENT A REDO MITRAL VALVE REPLACEMENT PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 11400M MITRIS 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 20535673 ↗
• InjurySep 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 33MM 11400M MITRAL VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER 33MM 11400M MITRAL VALVE AFTER AN IMPLANT DURATION OF 1 YEAR, 10 MONTHS AND 21 DAYS 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 20323822 ↗
• InjurySep 12, 2024Degraded; Degraded

  IT WAS REPORTED THAT PATIENT WITH A 33MM 11400M MITRAL VALVE, IMPLANTED IN THE TRICUSPID POSITION, HAS BEEN PLACED UNDER EVALUATION FOR A VALVE-IN-VALVE PROCEDURE AFTER IMPLANT DURATION OF ONE (1) YEAR, TEN MONTHS DUE TO DEGENERATION. THE PATIENT HAS BEEN TREATED WITH ANTICOAGULATION AND THE PROCEDURE HAS BEEN SCHEDULED.

  Patient problems: Insufficient Information

  MAUDE report 20204907 ↗
• InjurySep 5, 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 VALVE MODEL 11400M33 WAS EXPLANTED FROM THE MITRAL POSITION AFTER AN IMPLANT DURATION OF SIXTY-THREE (63) DAYS FOR UNKNOWN REASON. ANOTHER VALVE OF SAME MODEL AND SIZE WAS IMPLANTED IN REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 20145307 ↗
• InjuryJul 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY THAT A 33MM 11400M MITRAL VALVE, WAS EXPLANTED AFTER AN IMPLANT DURATION OF ONE (1) YEAR, TEN (10) MONTHS 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 19811266 ↗
• InjuryJul 8, 2024Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORD THAT A 33MM 11400M MITRAL VALVE IN MITRAL POSITION WAS EXPLANTED AND REPLACED WITH ANOTHER 33MM 11400M AFTER AN IMPLANT DURATION OF 2 MONTHS, 19 DAYS DUE TO MITRAL VALVE DEHISCENCE WITH PVL. THE PATIENT PRESENTED WITH FEVER AND CHILLS. PER MEDICAL RECORD, THE PATIENT PRESENTED WITH SUSPECT ENDOCARDITIS AND FEVER AND CHILLS, HOWEVER, CULTURES WERE NEGATIVE. INTRAOPERATIVELY, THE VALVE APPEARED TO BE IN AN AREA OF PERIVALVULAR DEHISCENCE THAT WAS RELATIVELY SMALL, NEAR THE POSTEROLATERAL COMMISSURE. THE VALVE WAS EXCISED AND A NEW 33MM 11400M MITRAL VALVE WAS SEATED AND TIED DOWN. THE VALVE WAS SEATED WELL WITH NO EVIDENCE OF PVL. THE PROCEDURE HAD NO COMPLICATIONS, AND THE PATIENT WAS RETURNED TO THE ICU IN CRITICAL CONDITION.

  Patient problems: Fever; Insufficient Information

  MAUDE report 19690903 ↗
• InjuryMay 24, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 33MM 11400M MITRIS VALVE IN MITRAL POSITION WAS EXPLANTED AND REPLACED WITH ANOTHER 33MM 11400M MITRIS VALVE AFTER AN IMPLANT DURATION OF ELEVEN (11) DAYS. THE PATIENT WAS IN RECOVERY POST-OPERATIVE. ADDITIONAL INFORMATION PROVIDED ON IDC; THE VALVE EXCHANGED WAS NOT DUE TO A DEFICIENCY OF THE ORIGINAL 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: Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 19397853 ↗
• InjuryMay 17, 2024Calcified; Calcified

  IT WAS REPORTED THAT A 33MM 11400M VALVE IN THE MITRAL POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 1 YEAR, 4 MONTHS AND 25 DAYS DUE SEVERE LEAFLET CALCIFICATION, SEVERE STENOSIS, DEGENERATION AND MILD REGURGITATION. THE PATIENT PRESENTED WITH ACUTE COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE. THE TMVR WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. THE PATIENT WAS DISCHARGED ON POD #2. PER MEDICAL RECORDS: THE PATIENT PRESENTED 1 YEAR 4MONTHS AND 5 DAYS POST REDO MVR IN ACUTE RESPIRATORY FAILURE SECONDARY ACUTE COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE, NYHA CLASS 111-1V, AND BIOPROSTHETIC AV AND MV STENOSIS. ECHO SHOWED EF 31%. TEE SHOWED BIOPROSTHETIC VALVES: SEVERE MS, MILD MR DUE TO DEGENERATIVE CHANGES OF MV, THE LEAFLETS SEVERELY CALCIFIED AND FIXED AND MODERATE TO SEVERE AS, AORTIC VALVE WITH CALCIFICATION, WELL SEATED TRICUSPID VALVE WITH MILD REGURGITATION, MILD LEAFLET THICKENING, AND DEGENERATIVE CHANGES OF THE VALVE. CATH REVEALED SEVERE LAD STENOSIS . THE PATIENT UNDERWENT PCI WITH STENT PLACEMENT (4/9/24), TAVR (4/11/24, 2024-08959-01) TWELVE DAYS PRIOR TO TMVR PRO

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 19347529 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 33MM 11400M VALVE IN THE MITRAL POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF TWENTY-SIX (26) DAYS DUE TO SEVERE MITRAL REGURGITATION SECONDARY TO MITRAL VALVE DEHISCENCE AND ENDOCARDITIS RE-INFECTION. THE PATIENT PRESENTED WITH SEPTIC SHOCK AND CARDIOGENIC SHOCK. THE EXPLANTED VALVE WAS REPLACED WITH ANOTHER 33MM 11400M VALVE. PER MEDICAL RECORDS, PATIENT HAD BEEN PLACED ON VA-ECMO DUE TO CARDIOGENIC WITH ELEVATED WBCS WITH EVIDENCE OF RIGHT SIDED PNEUMONIA. PATIENT WAS REPORTED TO BE IN MULTISYSTEM ORGAN FAILURE. VISUALIZATION OF THE VALVE UPON REMOVAL, THERE WAS FIBRINOUS SLOUGH ON THE VALVE THAT WAS SUSPICIOUS FOR INFECTIOUS MATERIAL. THE POSTERIOR ANNULUS APPEARED HIGHLY FRIABLE WITH SIGNIFICANT AMOUNTS OF SLOUGH, AND WAS CONCERNING FOR ANNULAR INFECTION. LARGE BITES INCORPORATING SOME LEFT ATRIAL TISSUE WERE TAKEN FROM THE POSTERIOR MITRAL ANNULUS. ALL MATERIAL WAS DEBRIDED AND A NEW 33MM MITRIS VALVE WAS SUTURED INTO PLACE. THE VALVE WAS SEATED WELL IN THE ANNULUS. THE AORTIC VALVE WAS INSPECTED WITH NO VISUALIZED INFECTION OF THE VALVE. THE PATIENT WAS HIGHLY COAGULOPATHIC AND THE PATIENT WENT TO VA-ECMO DUE TO INABILITY TO WEAN FROM BYPASS. THE

  Patient problems: Endocarditis

  MAUDE report 18913787 ↗
• InjuryJan 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 33MM 11400M MITRAL VALVE IN THE MITRAL POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF TWO (2) MONTHS, THREE (3) DAYS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE 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 18574755 ↗
• InjuryNov 2, 2023Perivalvular Leak; Insufficient Device Problem Information; Perivalvular Leak; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED THAT A 33MM 11400 MITRAL VALVE WAS EXPLANTED ON POD# 3 DUE TO RECURRENT PERIVALVULAR LEAK. THE EXPLANTED VALVE WAS REPLACED WITH A 31MM 11400M VALVE. PER MEDICAL RECORDS, PATIENT EXPERIENCED PARAVALVULAR LEAK POST-IMPLANTATION OF THE 33MM MITRAL VALVE AND HAD REDO-MVR WITH A 31MM 11400 VALVE. POST BYPASS TEE SHOWED ALL THE VALVES WERE COMPETENT. THE PATIENT WAS SENT BACK TO CVICU. ON POD#9 THE PATIENT REQUIRED PACEMAKER PLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 18062413 ↗
• InjuryAug 23, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS, IT WAS LEARNED THAT A 33MM 11400M MITRAL VALVE EXPLANTED AFTER AN IMPLANT DURATION OF 4 MONTHS, 18 DAYS DUE TO ENDOCARDITIS. THE EXPLANTED MITRAL VALVE WAS REPLACED WITH ANOTHER 33MM 11400M VALVE. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH SOB. THE PATIENT UNDERWENT REDO-AVR WITH A 27MM INSPIRIS (B)(4), REDO-MVR WITH A 33MM 11400M MITRIS VALVE, AND ECMO PLACEMENT. INTRAOPERATIVELY, MITRAL VALVE PROSTHESIS WAS DEHISCED WITH INFECTIOUS DESTRUCTION OF THE AORTO-MITRAL CURTAIN AND VEGETATIONS ON THE PROSTHETIC AORTIC VALVE. UNABLE TO ADEQUATELY DEBRIDE AND REPLACE THE MITRAL VALVE WITH THE AV IN PLACE, BOTH WERE REMOVED. THE AORTO-MITRAL CURTAIN HAD TORN SUTURE CAUSING MASSIVE PVL AND VALVE ROCKING. THE AORTO-MITRAL CURTAIN WAS REPAIRED. A NEW 33MM MITRIS VALVE AND 27MM INSPIRIS VALVE WERE IMPLANTED. THE PATIENT WAS TRANSFERRED TO ICU IN CRITICAL BUT STABLE CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 17605427 ↗
• DeathMay 8, 2023Entrapment of Device; Fluid/Blood Leak; Entrapment of Device; Fluid/Blood Leak

  IT WAS REPORTED A PATIENT WITH A 33MM 11400M MITRAL VALVE IMPLANTED ONE (1) DAY UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO MODERATE TO SEVERE CENTRAL REGURGITATION. THE 33MM 11400M MITRAL VALVE WAS IMPLANTED AND SUBSEQUENTLY HAD SIGNIFICANT REGURGITATION. THE MVR WAS PERFORMED ON AN EMERGENCY BASIS. THE PATIENT HAD A BAD ANTERIOR WALL MI AND WAS TREATED IN THE CATH LAB, BUT THE PATIENT NEEDED AN MVR DUE TO A RUPTURED PAPILLARY MUSCLE AS A RESULT OF THE MITRAL INSUFFICIENCY. THE SURGEON DESCRIBED THE REGURGITATION AS MODERATE TO SEVERE CENTRAL REGURGITATION BUT DECIDED NOT TO GO BACK ON PUMP GIVEN THE CONDITION OF THE PATIENT. PATIENT WAS VERY SICK FROM THE MITRAL INSUFFICIENCY AND NOT IN VERY GOOD CONDITION. THE PATIENT WAS PUT ON BALLOON PUMP. SURGEON STATED SHE REMOVED THE MITRIS HOLDER SYSTEM, BOTH THE HANDLE AND THE HOLDER, BEFORE SECURING THE VALVE DOWN WITH COR KNOTS. SURGEON AND EW REP DISCUSSED THE POSSIBILITY AND LIKELIHOOD THAT A SUTURE MAY HAVE ENTRAPPED ONE OF THE STENT POSTS. THE SURGEON DID NOT THINK THAT THE PATIENT WOULD TOLERATE ANOTHER PUMP RUN, SO THE DECISION WAS MADE WITH CARDIOLOGY TO A TMVR. THE TMVR WAS PERFORMED WITH A 29MM 9600TFX. THE PATIENT POST OPERATIV

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 16888006 ↗
• InjuryMar 24, 2023Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 33MM 11400M VALVE IN THE TRICUSPID POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 MONTHS AND 6 DAYS DUE TO CANDIDA DUBLINIENSIS ENDOCARDITIS. THE EXPLANTED VALVE WAS REPLACED WITH A 31MM 11400M MITRAL VALVE.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 16612859 ↗