MITRIS RESILIA Mitral Valve 11400M (REF 11400M31)Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00690103205565), received between Jan 31, 2023 and Sep 21, 2026 — classified as 1 death, 36 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (23 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 37 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Device Dislodged or Dislocated

  Patient problems: Fever

  MAUDE report 50848999 ↗
• InjuryJun 11, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 31MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 10 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED DEVICE WAS REPLACED WITH A 33MM 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 25472455 ↗
• InjuryApr 11, 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 31MM 11400M MITRAL VALVE IMPLANTED IN THE TRICUSPID POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 MONTHS AND 9 DAYS DUE TO RECURRENT ENDOCARDITIS. THE EXPLANTED VALVE WAS REPLACED WITH A 31MM 11400M VALVE. PER MEDICAL RECORDS, THE PATIENT WAS ADMITTED FOR SEPSIS DUE TO E. FAECIUM AND MSSA BACTEREMIA, AND SACROILIITIS. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS. THE PATIENT UNDERWENT REDO-TVR WITH A 31MM 11400M VALVE, REDO-MVR WITH A NON-EDWARDS VALVE. POST BYPASS TEE SHOWED BOTH VALVES WITH NO PVL. THE PATIENT TOLERATED THE PROCEDURE WITH NO IMMEDIATE COMPLICATIONS.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 24849252 ↗
• InjuryMar 31, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 31MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 17 DAYS 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 24749561 ↗
• InjuryMar 23, 2026Perivalvular Leak; Device Dislodged or Dislocated

  IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 31MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 MONTH, 25 DAYS DUE TO SUTURES TORN OUT CAUSING SEVERE PVL. THE EXPLANTED VALVE WAS REPLACED WITH A 31MM 11400M VALVE. PER MEDICAL RECORDS, PATIENT PRESENTED WITH HEART FAILURE NYHA 3-4. ECHO REVEALED SEVERE PARAVALVULAR LEAK AND UNDERWENT SUCCESSFUL PLACEMENT OF AMPLATZER PLUG X2. HIS SYMPTOMS IMPROVED BUT CONTINUED TO HAVE A LEAK AND WAS BROUGHT BACK TO THE OR FOR REDO MVR MEDIAN STERNOTOMY. INTRA-OP TEE SHOWS SEVERE MITRAL REGURGITATION WITH A PARAVALVULAR JET AT P2. ON INSPECTION THERE WAS DEHISCENCE OF THE VALVE FROM THE ANNULUS AT P2. THE PREVIOUS STITCHES APPEARED TO HAVE BEEN APPROPRIATELY PLACED THROUGH THE ANNULUS BUT TORE THROUGH. THE PREVIOUS MV AND AMPLATZER DEVICES WERE REMOVED. A STRIP OF FELT WAS USED TO RECONSTRUCT THE POSTERIOR ANNULUS. ADDITIONAL STITCHES WERE PLACED AROUND THE ANNULS LEAVING PLEDGET ON THE ATRIAL SIZE EVERTING THE EDGE. A NEW 31MM 11400M WAS SEATED AND TIED INTO PLACE WITHOUT DIFFICULTY. POSTOP TEE SHOWED A WELL-SEATED VALVE IN THE MITRAL POSITION WITH NO LEAK, NO LVOT OBSTRUCTION, AND MG 2MMHG. THE PA

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24659609 ↗
• InjuryFeb 26, 2026Perivalvular Leak

  IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS THAT A PATIENT WITH A 11400M 31MM MITRAL VALVE UNDERWENT A PLUG PLACEMENT PROCEDURE AFTER AN IMPLANT DURATION OF 4 MONTHS DUE TO PERIVALVULAR LEAK. 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 24456947 ↗
• InjuryFeb 17, 2026Perivalvular Leak

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORD THAT A 31MM 11400M MITRAL VALVE WAS EXPLANTED AND REPLACED WITH A 29MM 11400M MITRAL VALVE AFTER AN IMPLANT DURATION OF 1 YEAR, 1 MONTH, AND 5 DAYS DUE TO SEVERE PERIVALVULAR LEAK. THE PATIENT PRESENTED WITH FATIGUE. PER MEDICAL RECORDS, PATIENT PRESENTED WITH FATIGUE AND WAS FOUND TO HAVE PVL OF PREVIOUSLY PLUGGED MITRAL VALVE, AND LV PSEUDOANEURYSM. INTRAOPERATIVELY, MITRAL VALVE WAS EXCISED ALONG WITH MULTIPLE PLUGS. POSTERIOR MITRAL ANNULAR CALCIFICATION WAS NOTED AND DEBRIDED. A 29MM 11400M VALVE WAS SUTURED INTO PLACE WITH NO EVIDENCE OF PVL. CONCOMITANTLY, THE TRICUSPID RING WAS EXPLANTED AND REPLACED WITH A 33MM VALVE DUE TO LEAFLET MALCOAPTATION WITH SEVERE REGURGITATION. PATIENT WAS WEANED FROM BYPASS WITHOUT DIFFICULTY. ALL VALVES SEATED WELL. 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 S

  Patient problems: Fatigue

  MAUDE report 24365958 ↗
• InjuryDec 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 31MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF SIX (6) MONTHS, AND 13 DAYS DUE TO ENDOCARDITIS. THE PATIENT PRESENTED GENERAL WEAKNESS. THE EXPLANTED VALVE WAS REPLACED WITH A 31MM 11400M MITRAL VALVE. PER MEDICAL RECORDS, THE PATIENT ACUTELY DECOMPENSATED WITH ACUTE RESPIRATORY DISTRESS, FLASH PULMONARY EDEMA, AND WORSENING OF MITRAL VALVE DEHISCENCE AFTER HOSPITAL ADMISSION.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 23897147 ↗
• InjuryDec 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT A 31MM 11400M MITRAL VALVE, IMPLANTED IN THE TRICUSPID POSITION, WAS EXPLANTED AFTER AN IMPLANT DURATION OF TWO (2) YEARS, NINE (9) MONTHS DUE TO ENDOCARDITIS. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 11400M VALVE. PER MEDICAL RECORDS, THE PATIENT UNDERWENT REDO MVR WITH A 29MM 11400M VALVE. POST CARDIOPULMONARY BYPASS, THERE WAS A MILD-MODERATE PERIVALVULAR LEAK WAS NOTED ON THE ANTERIOR SURFACE. DECISION WAS MADE TO LEAVE IT ALONE DUE TO IT BEING IN A DIFFICULT AREA TO FIX. PROTAMINE WAS ADMINISTERED AND EXCELLENT HEMOSTASIS WAS FOUND THROUGHOUT THE FIELD. THE PATIENT WAS TAKEN TO THE ICU IN STABLE CONDITION HAVING TOLERATED THE PROCEDURE WELL. THERE WERE NO COMPLICATIONS APPARENT.

  Patient problems: Insufficient Information

  MAUDE report 23830674 ↗
• InjuryDec 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE REPORT RECEIVED FROM AUSTRALIA A VALVE MODEL 11400M31 WAS EXPLANTED AFTER TWO (2) DAYS FROM MITRAL POSITION DUE TO "THROMBUS-LIKE SUBSTANCE" FOUND ON LEAFLETS LEADING TO MODERATE REGURGITATION. AS REPORTED, THE INITIAL PROCEDURE WAS A VENTRICULAR SEPTAL DEFECT (VSD) CLOSURE AND POSTOPERATIVELY TO THIS PROCEDURE, THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND ULTIMATELY UNDERWENT A MITRAL VALVE REPLACEMENT TO REDUCE PRESSURE ON THE VSD PATCH. TWO DAYS AFTER THE VALVE IMPLANT, THE VALVE DEMONSTRATED REGURGITATION AND AN INTRAVALVULAR LEAK, WHICH WAS CONFIRMED BY CT IMAGING. THERE WAS NO REGURGITATION NOTED IMMEDIATELY POST 11400M VALVE IMPLANTATION. THE PATIENT WAS TAKING ASPIRIN AT THE TIME OF THE THROMBOSIS DIAGNOSIS. IN REPLACEMENT, A NON-EDWARDS VALVE WAS IMPLANTED. THE PATIENT WAS NOTED AS TO BE IN STABLE CONDITION.

  Patient problems: Insufficient Information; Thrombosis/Thrombus

  MAUDE report 23700289 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE REPORT RECEIVED FROM GERMANY, THIS VALVE MODEL 11400M31 IMPLANTED IN MITRAL POSITION WAS SHOWING A MEAN TRANSVALVULAR GRADIENT OF 7-8MMHG DUE TO ENDOCARDITIS CAUSED BY STAPHYLOCOCCUS EPIDERMIS AFTER AN IMPLANT DURATION OF FIFTY-FIVE (55) DAYS. THE PATIENT HAD LIMITED EXERCISE CAPACITY AND DYSPNEA ON EXERTION (NYHA II-III) AT THE BEGINNING BUT BECAME ASYMPTOMATIC. APPROPRIATE ANTIBIOTIC THERAPY WAS STARTED. THE PATIENT WAS ADMITTED TO THE CLINICAL FOR A SURGICAL INTERVENTION FOR THE DIAGNOSED EARLY PROSTHETIC ENDOCARDITIS THE BLOOD CULTURES IMMEDIATELY BEFORE THE PLANNED SURGERY (DURING THE ANTIBIOTIC-FREE WINDOW) REMAINED NEGATIVE. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED, CONSISTENT WITH THE PATIENT'S CLINICAL STATUS, AN IMPROVEMENT OF THE LOCAL FINDINGS WITH HARDLY DETECTABLE DEPOSITS ON THE MITRAL VALVE PROSTHESIS AFTER 6 WEEKS OF ANTIBIOTIC. A CONSERVATIVE APPROACH WAS CHOSEN. ANTIBIOTIC THERAPY WAS DISCONTINUED, AND THE PATIENT WAS DISCHARGED TO OUTPATIENT CARE UNDER SUPERVISION WITHOUT THE NEED FOR REINTERVENTION.

  Patient problems: Endocarditis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23407147 ↗
• InjuryOct 12, 2025Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND RECORDS THAT A PATIENT WITH A 31MM 11400M MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 YEARS, 7 MONTHS DUE TO DEGENERATION AND REGURGITATION. THE PATIENT PRESENTED WITH HEART FAILURE. THE PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE.

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

  MAUDE report 23275632 ↗
• InjuryAug 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 31MM 11400M MITRIS VALVE UNDERWENT REDO MITRAL VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF SIX (6) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 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 22746657 ↗
• InjuryAug 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 31MM 11400M MITRIS VALVE IN MITRAL POSITION WAS EXPLANTED AND REPLACED WITH ANOTHER 31MM 11400M MITRIS VALVE AFTER AN IMPLANT DURATION OF 8 MONTHS, 19 DAYS DUE TO UNKNOWN REASON. REPORTEDLY, THE 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: Insufficient Information

  MAUDE report 22699389 ↗
• InjuryAug 4, 2025Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 31 MM 11400M MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 YEARS, 8 MONTHS DUE TO UNKNOWN REASONS. THE PROCEDURE WAS PERFORMED WITH A 29 MM 9600TFX TRANSCATHETER VALVE.

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

  MAUDE report 22699247 ↗
• InjuryJul 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 31MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS, 3 MONTHS 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: Insufficient Information

  MAUDE report 22544193 ↗
• InjuryMay 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 31MM 11400M MITRAL VALVE IN THE MITRAL POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 MONTHS AND 5 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 22006903 ↗
• InjuryMay 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 31MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 31MM 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 21978911 ↗
• InjuryApr 30, 2025Perivalvular Leak; Device Dislodged or Dislocated; Perivalvular Leak; Device Dislodged or Dislocated

  PER THE REPORT RECEIVED FROM GERMANY, A PATIENT WITH A VALVE MODEL 11400M31 IMPLANTED IN THE MITRAL POSITION WAS PLANNED FOR A REDO SURGERY AFTER AN IMPLANT DURATION OF FIVE (5) MONTHS DUE TO SEVERE PARAVALVULAR LEAK (PVL). ACCORDING TO CORE LAB ECHO RESULTS, THE PVL WAS ALREADY PRESENT ONE (1) MONTH AFTER THE IMPLANT. DURING THE INITIAL PROCEDURE, THE DEVICE WAS IMPLANTED WITH INTRA-ANNULAR (EVERTING) SUTURES USING AN INTERRUPTED SUTURE TECHNIQUE WITH PLEDGETS, AND THERE WERE NO REPORTED COMPLICATIONS. REPORTEDLY, THE MOST LIKELY ROOT CAUSE FOR THE PVL MIGHT BE THAT THE SUTURE LOOSENED / RUPTURED FROM THE ANNULUS TISSUE. HOWEVER, THIS WAS ONLY AN ASSUMPTION AND CAN ONLY BE CONFIRMED DURING THE REDO PROCEDURE. THE PATIENT DID NOT PRESENT ANY SYMPTOMS DURING THE LAST VISIT AND WAS DISCHARGED HOME AWAITING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937887 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; 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 A MITRIS RESILIA VALVE MODEL 11400M31 IMPLANTED IN THE MITRAL POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF TWO (2) YEARS AND ONE (1) MONTH FOR UNKNOWN REASON. A 27 MM SURGICAL VALVE WAS IMPLANTED IN REPLACEMENT. THE PATIENT WAS 63 YEARS OLD AT THE TIME OF ORIGINAL DEVICE IMPLANTATION.

  Patient problems: Air Embolism; Embolism/Embolus; Endocarditis; Insufficient Information

  MAUDE report 21641398 ↗
• InjuryFeb 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 31MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 MONTHS, 3 DAYS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 33MM 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: Insufficient Information

  MAUDE report 21400590 ↗
• InjuryFeb 13, 2025Thickening of Material; Thickening of Material

  IT WAS REPORTED THAT A 31MM 11400M MITRAL VALVE WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 1 YEAR, 10 MONTHS DUE TO THICKENED AND IMMOBILE LEAFLETS WITH SEVERE STENOSIS AND MODERATE REGURGITATION. PER MEDICAL RECORDS THE PATIENT PRESENTED IN ACUTE ON CHRONIC HEART FAILURE NYHA IV, DYSPNEA, EDEMA, AND FATIGUE. PRE-OP TEE NOTED SIGNIFICANTLY THICKENED AND IMMOBILE LEAFLETS. A 9755RSL 29MM TRANSCATHETER VALVE WAS IMPLANTED. INSPECTION OF THE VALVE REVEALED GOOD 3 LEAFLET MOTION WITH NO VALVULAR OR PERIVALVULAR LEAK. THE PATIENT TOLERATED THE PROCEDURE WELL BUT REMAINED IN GUARDED CONDITION AT THE CONCLUSION.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 21376371 ↗
• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY THAT DURING THE IMPLANT OF A 11400M 31MM MITRAL VALVE, THE NATIVE AORTIC VALVE GOT DAMAGED, REQUIRING AN UNPLANNED AVR. PER MEDICAL RECORDS THE PATIENT PRESENTED WITH NATIVE MITRAL VALVE LEAFLET PROLAPSE AND UNDERWENT MVR VIA RIGHT MINITHORACOTOMY. UPON IMPLANTING OF THE 31MM MITRAL VALVE, ONE OF THE COR-KNOTS MISFIRED, CUTTING THE VALVE SUTURES. THESE WERE REPAIRED AND THE PATIENT WAS WEANED FROM BYPASS. TEE SHOWED A MODERATE PERIVALVULAR LEAK NEAR A1/A2. THE SURGEON ELECTED TO RE-REPLACE THE VALVE VIA FULL STERNOTOMY. UPON EXPLANTING THE NEWLY SEATED VALVE, IT WAS EVIDENT THAT TWO SEPARATE COR-KNOT FASTENERS (1 ALONG THE ANTERIOR LEAFLET AT A1/A2, THE SITE OF THE PVL, AND THE OTHER ALONG THE POSTERIOR LEAFLET) HAD MISFIRED, AND THE FASTENERS BECAME EASILY DISLODGED FROM THE SUTURES WITH MINIMAL MANIPULATION. THE SURGEON BELIEVED THIS WAS THE SOURCE OF PVL. THE 31MM VALVE WAS REPLACED WITH ANOTHER 31MM VALVE, AND THERE WAS NO LEAK. THE PATIENT WAS WEANED FROM BYPASS. NEW MODERATE-TO-SEVERE AORTIC REGURGITATION WAS NOTED FROM A RESTRICTED NONCORONARY CUSP, LIKELY DUE TO INJURY CAUSE BY MISFIRED COR-KNOTS DURING MITRAL VALVE SUTURING. THER

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21103403 ↗
• InjuryJan 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 31MM 11400M MITRAL VALVE, IMPLANTED IN THE TRICUSPID POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEAR, 3 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 21060084 ↗
• InjuryDec 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 31MM 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 20926296 ↗