CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIALBIOPROSTHESIS - MITRAL 6900PTFX (REF 6900PTFX31)Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00690103163612), received between Jun 15, 2021 and Sep 19, 2025 — classified as 28 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (14 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 28 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 31MM 6900PTFX PERICARDIAL MITRAL VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, NINE (9) MONTHS DUE TO UNKNOWN REASONS. THE TMVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 23102610 ↗
• InjurySep 4, 2025Calcified; Calcified

  IT WAS REPORTED THAT A 31MM 6900PTFX MITRAL VALVE IMPLANTED IN THE TRICUSPID POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 3 MONTHS DUE TO CALCIFICATION WITH STENOSIS. THE PATIENT PRESENTED WITH LOWER EXTREMITY SWELLING. TTVR WAS COMPLETED WITH A 29MM 9755RSL TRANSCATHETER VALVE AND PATIENT WAS STABLE AT THE END OF THE PROCEDURE.

  Patient problems: Swelling/ Edema

  MAUDE report 22965487 ↗
• InjuryJul 3, 2025Device Stenosis; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 31MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 11 MONTHS DUE TO REGURGITATION AND STENOSIS. PATIENT PRESENTED WITH SHORTNESS OF BREATH AND CHEST PAIN. THE PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. THIS IS 78-YEAR-OLD PATIENT. 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: Chest Pain; Dyspnea

  MAUDE report 22398172 ↗
• InjuryJun 12, 2025Calcified; Calcified

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 31MM 6900PTFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS DUE TO CALCIFICATION AND STENOSIS. PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11400M MITRIS RELISA MITRAL VALVE. PATIENT WAS STABLE AND WAS DISCHARGED ON POD#7 THIS IS A 69-YEAR-OLD FEMALE PATIENT PER PATHOLOGY, EXPLANTED MITRAL VALVE CONSISTED OF TAN-YELLOW DYSTROPHIC CALCIFICATIONS. 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 22198659 ↗
• InjuryJun 7, 2025Device Stenosis; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 31MM 6900PTFX IN THE MITRAL POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 6 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND FATIGUE. TMVR WAS COMPLETED WITH A 29MM 9755RSL TRANSCATHETER VALVE AND PATIENT WAS IN RECOVERY AT THE END OF THE 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: Dyspnea; Fatigue

  MAUDE report 22163773 ↗
• InjuryMay 12, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED AND LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 31MM 6900PTFX MITRAL VALVE WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 9 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. TMVR WAS COMPLETED WITH A 29MM 9755RSL TRANSCATHETER VALVE AND PATIENT WAS IN RECOVERY IN STABLE CONDITION AT THE END OF THE PROCEDURE.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 22007010 ↗
• InjuryApr 24, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 31MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 5 MONTHS DUE TO MITRAL STENOSIS. THE PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 29MM 9755RSL VALVE.

  Patient problems: Fatigue; Insufficient Information

  MAUDE report 21901263 ↗
• InjuryMar 28, 2025Calcified; Insufficient Device Problem Information; Patient Device Interaction Problem; Calcified; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS LEARNED THROUGH COMPLAINT# (B)(4) THAT A PATIENT WITH A 31MM 6900PTFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 9 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 11400M VALVE. THE PATIENT WAS TAKEN 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: Dyspnea; Insufficient Information

  MAUDE report 21727282 ↗
• InjuryJan 31, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 31MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 3 MONTHS DUE TO SEVERE STENOSIS. PATIENT PRESENTED WITH HEART FAILURE, SHORTNESS OF BREATH, FATIGUE, AND CHEST PAIN. THE PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. PATIENT WAS STABLE POST PROCEDURE AND WAS DISCHARGED ON POD#16. THIS IS A 77-YEAR-OLD MALE PATIENT.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure; Swelling/ Edema

  MAUDE report 21289110 ↗
• InjuryDec 3, 2024Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT A 31MM 6900PTFX MITRAL VALVE IN THE TRICUSPID POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 11 MONTHS DUE TO SEVERE TRICUSPID REGURGITATION. THE PROCEDURE WAS COMPLETED WITH A 29MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 20834428 ↗
• InjuryDec 1, 2024Degraded; Degraded

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 31MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, SIX (6) MONTHS DUE TO DEGENERATION AND STENOSIS. PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. PATIENT WAS STABLE, IN RECOVERY AND WAS DISCHARGED ON POD#1. THIS IS A 79-YEAR-OLD MALE PATIENT 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 20815772 ↗
• InjuryNov 26, 2024Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  AS REPORTED BY THE EDWARDS LIFESCIENCES AFFILIATE IN TURKEY, A 6900PTFX31 VALVE MODEL WAS EXPLANTED FROM A 72-YEAR-OLD PATIENT AFTER AN IMPLANT DURATION OF ONE (1) YEAR AND TWO (2) MONTHS DUE TO SEVERE STENOSIS AND HIGH GRADIENTS OBSERVED ON ECHO. UPON EXPLANT, FUSION AT THE VALVE COMMISSURE WAS OBSERVED, INDICATING CONGLUTINATION OF THE LEAFLETS AND COMMISSURAL FUSION. HOWEVER, THE LEAFLETS COULD BE SEPARATED UPON TOUCHING WITH A MEDICAL TOOL. THE PATIENT REPORTEDLY EXPERIENCED SUDDEN EPISODES OF FATIGUE STARTING FROM POSTOPERATIVE MONTH 7. A 31MM NON-EDWARDS MECHANICAL VALVE WAS SUCCESSFULLY IMPLANTED IN REPLACEMENT WITH NO REPORTED COMPLICATION FOR THE PATIENT. PATIENT WAS DISCHARGED AFTER THE REDO SURGERY.

  Patient problems: Fatigue; Thrombosis/Thrombus

  MAUDE report 20780203 ↗
• InjurySep 23, 2024Thickening of Material; Device Stenosis; Thickening of Material; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS THAT A PATIENT WITH A 31MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, TEN MONTHS DUE TO THICKENED LEAFLETS, ABNORMAL LEAFLET MOTION, SEVERE MITRAL STENOSIS, AND REGURGITATION. PATIENT PRESENTED WITH HEART FAILURE, AND SHORTNESS OF BREATH. THE TMVR WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS DISCHARGED POD#1 IN STABLE CONDITION. PER MEDICAL RECORDS, THE PATIENT WAS PRESENTED WITH FATIGUE AND DOE IN THE SETTING OF NYHA CLASS III HF. CARDIAC WORK UP REVEALED SEVERE PROSTHETIC MITRAL VALVE STENOSIS AND MILD REGURGITATION. TEE SHOWED THICKENED AND HYPERECHOIC LEAFLETS WITH ABNORMAL MOTION. THE PATIENT UNDERWENT SUCCESSFUL TMVR WITH NO REGURGITATION, NOR PVL. THE PATIENT WAS ABLE TO AMBULATE WELL AND WAS DISCHARGED HOME ON POD #1. 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

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 20286507 ↗
• InjurySep 6, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A 31MM 6900PTFX VALVE IN THE MITRAL POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 11 MONTHS DUE TO STENOSIS. THE TMVR WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 20163639 ↗
• InjuryJul 11, 2024Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 31MM 6900PTFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 7 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 11400M MITRIS RESILIA 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: Dyspnea; Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 19726805 ↗
• InjuryJun 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY THAT A 31MM VALVE IN TRICUSPID POSITION WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 11 MONTHS DUE TO UNKNOWN REASONS. A 29MM TRANSCATHETER VALVE WAS IMPLANTED. 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 19536701 ↗
• InjuryMay 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 31MM 6900PTFX PERICARDIAL MITRAL VALVE UNDERWENT A REDO MITRAL VALVE REPLACEMENT PROCEDURE AFTER AN IMPLANT DURATION OF THREE (3) YEARS, FIVE (5) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 31MM 11400M MITRIS VALVE.

  Patient problems: Insufficient Information

  MAUDE report 19231418 ↗
• InjuryJul 17, 2023Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  IT WAS LEARNED FROM IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 31MM 6900PTFX PERICARDIAL MITRAL VALVE UNDERWENT A REDO MITRAL VALVE REPLACEMENT PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 1 MONTH DUE TO MITRAL STENOSIS. THE PATIENT INITIALLY PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. THE EXPLANTED VALVE WAS REPLACED WITH A 31MM 11400M VALVE. THE PATIENT WAS NOTED TO BE IN STABLE CONDITION IN THE ICU POST PROCEDURE.

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

  MAUDE report 17334842 ↗
• InjuryJun 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY THAT A 31MM 6900PTFX MITRAL VALVE WAS EXPLANTED AND REPLACED WITH A 33MM 6900PTFX VALVE AFTER AN IMPLANT DURATION OF EIGHT YEARS AND SEVEN MONTHS 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 17176787 ↗
• InjuryMay 19, 2023Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 6900PTFX 31MM MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 22 DAYS DUE TO STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE, SHORTNESS OF BREATH, AND DIZZINESS. THE PROCEDURE WAS PERFORMED WITH A 29MM 9600TFX TRANSCATHETER VALVE. THE PATIENT IS IN RECOVERY POST PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 16965424 ↗
• InjuryMay 5, 2023Gradient Increase; Adverse Event Without Identified Device or Use Problem; Gradient Increase; Adverse Event Without Identified Device or Use Problem

  THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION, IT WAS LEARNED THAT A 31MM 6900PTFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEAR, 4 MONTHS DUE TO VALVE THROMBOSIS CAUSING MITRAL STENOSIS. BLOOD CULTURES WERE NEGATIVE. PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE EXPLANTED VALVE WAS REPLACED WITH A 33MM 6900PTFX VALVE. THE PATIENT WAS STABLE. 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; Thrombosis/Thrombus

  MAUDE report 16882154 ↗
• InjuryMar 3, 2023Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 31MM 6900PTFX MITRAL VALVE IMPLANT FOR 5 YEARS AND 6 MONTHS UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO SEVERE STENOSIS AND MILD REGURGITATION WITH CENTRAL JET. THE PATIENT PRESENTED WITH ACUTE ON CHRONIC HEART FAILURE. TMVR WAS SUCCESSFULLY PERFORMED WITH A 29MM 9600TFX VALVE. THE PATIENT WAS TRANSFERRED BACK TO THE ICU FOR POSTOPERATIVE CARE.

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

  MAUDE report 16479879 ↗
• InjuryNov 4, 2022Fluid/Blood Leak; Gradient Increase; Difficult to Open or Close; Insufficient Device Problem Information; Fluid/Blood Leak; Gradient Increase; Difficult to Open or Close; Insufficient Device Problem Information

  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. IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT THIS PATIENT WITH A 6900PTFX 31MM MITRAL VALVE, IMPLANTED FOR TWO YEARS AND SIX MONTHS, UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO UNKNOWN REASONS. THE TMVR WAS PERFORMED WITH A 9600TFX 29MM.

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

  MAUDE report 15723772 ↗
• InjuryJul 1, 2022Calcified; Degraded; Fluid/Blood Leak; Gradient Increase; Insufficient Device Problem Information; Patient Device Interaction Problem; Calcified; Degraded; Fluid/Blood Leak; Gradient Increase; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT THIS PATIENT WITH A 6900PTFX 31MM MITRAL VALVE, IMPLANTED FOR FIVE (5) YEARS AND SEVEN (7) MONTHS, IS BEING EVALUATED FOR A VALVE-IN-VALVE PROCEDURE DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 14895591 ↗
• InjuryApr 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THIS PATIENT WITH A 6900PTFX 31 MM VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO MITRAL REGURGITATION. IMPLANT DURATION OF THE PRE-EXISTING SURGICAL VALVE IS APPROXIMATELY TWO (2) YEARS AND FIVE (5) MONTHS. THE TAVR WAS PERFORMED WITH AN EDWARDS TRANSCATHETER VALVE. NO OTHER DETAILS AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 14227722 ↗