CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis 2700TFX (REF 2700TFX27MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00690103194050), received between Mar 10, 2022 and Feb 10, 2026 — classified as 25 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (13 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 8 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11500A 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 24309631 ↗
• InjuryJan 2, 2026Calcified; Insufficient Device Problem Information

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 3 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 2MM 11500A 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 23952314 ↗
• InjuryJul 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 2700TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 8 MONTHS DUE TO UNKNOWN REASONS. THE PROCEDURE WAS PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22485583 ↗
• InjuryJul 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 27MM 2700TFX AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AND REPLACED WITH A 25MM 11500A RESILIA AORTIC VALVE AFTER AN IMPLANT DURATION OF 5 YEARS, 2 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 22484574 ↗
• InjuryJun 16, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 2700TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 6 MONTHS DUE TO STENOSIS. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22213470 ↗
• InjuryMay 5, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A 27MM 2700TFX AORTIC VALVE IN AORTIC POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 3 MONTHS DUE TO STENOSIS. TAVR WAS COMPLETED WITH A 29MM 9600TFX TRANSCATHETER VALVE AND PATIENT WAS IN RECOVERY AT THE END OF THE PROCEDURE.

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

  MAUDE report 21960711 ↗
• InjuryMar 28, 2025Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 9 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A 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 21727266 ↗
• InjuryJan 3, 2025Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 2700TFX AORTIC VALVE, IMPLANTED IN THE PULMONIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF NINE (9) YEARS, TWO (2) MONTHS DUE TO STENOSIS. THE PROCEDURE WAS PERFORMED WITH A 26MM 9600TFX TRANSCATHETER VALVE. THE VALVE WAS SUCCESSFULLY IMPLANTED WITH NO COMPLICATIONS.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 21072955 ↗
• InjuryDec 9, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 2700TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 11 MONTHS DUE TO STENOSIS. THE PROCEDURE WAS PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 20885962 ↗
• InjuryDec 1, 2024Degraded; Intravalvular regurgitation; Degraded; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 2700TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 11 MONTHS DUE TO REGURGITATION. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 20815782 ↗
• InjuryNov 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 27MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS AND ELEVEN (11) MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED DEVICE WAS REPLACED WITH A 25MM 11060A AORTIC VALVED CONDUIT. 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 20707386 ↗
• InjuryNov 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MODEL 2700TFX 27MM PERICARDIAL AORTIC VALVE WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 4 MONTHS DUE TO UNKNOWN REASONS. A 9755RSL 26MM TRANSCATHETER VALVE WAS IMPLANTED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 20630695 ↗
• InjuryAug 7, 2024Calcified; Calcified

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 27MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS, 1 MONTH DUE TO CALCIFICATION, MODERATE DEGENERATION AND STENOSIS . PATIENT PRESENTED WITH SHORTNESS OF BREATH, CHEST PAIN ,AND SYNCOPE. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A INSPIRIS RELISA VALVE. PATIENT WAS STABLE POST PROCEDURE AND WAS DISCHARGED ON POD#8 THIS IS A 62-YEAR-OLD MALE PATIENT WITH A HISTORY OF CAD, HTN AND ATHEROSCLEROSIS. 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

  Patient problems: Chest Pain; Dyspnea; Swelling/ Edema

  MAUDE report 19934417 ↗
• InjuryMay 9, 2024Calcified; Patient Device Interaction Problem; Calcified; Patient Device Interaction Problem

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 27MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF THREE (3) YEARS, NINE MONTHS DUE TO SEVERE CALCIFICATION, SEVERE PANNUS, AND SEVERE STENOSIS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11500A VALVE. PER MEDICAL RECORDS, PRE-OP ECHO SHOWS SEVERE AS CAUSED BY PROSTHETIC THICKENING/CALCIFICATION. THE PATIENT ARRIVES IN THE OR IN FLORID ACUTE ON CHRONIC BI-VENTRICULAR FAILURE WITH SEVERE TR AND RV DYSFUNCTION. EMERGENT SALVAGE REDO AVR AND TVR (WITH KAY STITCH) WAS PERFORMED. THE PREVIOUS VALVE WAS REPLACED WITH A 27MM INSPIRIS VALVE. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO IMMEDIATE COMPLICATIONS. PER HOSPITAL PATHOLOGY REPORT, AORTIC BIOPROSTHETIC VALVE: SEVERE CALCIFICATION, SEVERE PANNUS FORMATION, AND LIMITED MOBILITY OF ALL 3 LEAFLETS (GROSS EXAM ONLY). 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 IMPLANTE

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 19280129 ↗
• InjuryMar 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 2700TFX AORTIC VALVE HAS BEEN PLACED UNDER EVALUATION/CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 10 MONTHS DUE TO UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 18965861 ↗
• InjurySep 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 27MM 2700TFX PERICARDIAL AORTIC VALVE UNDERWENT A REDO AORTIC VALVE REPLACEMENT PROCEDURE AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, FOUR (4) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11060A AORTIC VALVED CONDUIT.

  Patient problems: Insufficient Information

  MAUDE report 17674296 ↗
• InjuryJun 21, 2023Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A MODEL 2700TFX 27MM PERICARDIAL AORTIC VALVE WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 5 MONTHS DUE TO STENOSIS. PATIENT PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. A 9755RSL 26MM TRANSCATHETER VALVE WAS SUCCESSFULLY IMPLANTED.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 17175368 ↗
• InjuryJun 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 2700TFX PERICARDIAL AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SIX (6) YEARS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A INSPIRIS VALVE. THE PATIENT WAS TRANSFERRED TO THE SICU POST PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 17171972 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND ADDITIONAL INFORMATION THAT A PATIENT WITH A 27MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 12 DAYS DUE TO ENDOCARDITIS. THE PATIENT PRESENTED WITH HEART FAILURE. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A VALVE. THE PATIENT WAS STABLE AND IN ICU POST PROCEDURE.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 17114278 ↗
• InjuryJun 5, 2023Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A MODEL 2700TFX 27MM PERICARDIAL AORTIC VALVE WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 9 MONTHS DUE TO STENOSIS. THE PATIENT WAS PRESENTED WITH SHORTNESS OF BREATH, ORTHOPNEA, FATIGUE, LE EDEMA. A 9600TFX 29MM TRANSCATHETER VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS MONITORED IN THE CCU POST PROCEDURE FOR A DAY AND DISCHARGED HOME UNDER STABLE CONDITIONS AT POD #1. THIS IS A 67-Y-O MALE WITH A HISTORY OF HFPEF, HTN, TOBACCO USE DISORDER, PRIOR AVR.

  Patient problems: Dyspnea; Fatigue; Swelling/ Edema

  MAUDE report 17061455 ↗
• InjuryMar 24, 2023Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT THIS PATIENT WITH A 27MM 2700TFX AORTIC VALVE, IMPLANTED FOR 5 YEARS, UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO STENOSIS. THE PATIENT CHIEF COMPLAINT WAS HEART FAILURE, SHORTNESS OF BREATH. TAVR WAS PERFORMED WITH A 9600TFX29A VALVE WITHOUT COMPLICATIONS. THE PATIENT TOLERATED PROCEDURE WELL AND WAS SENT TO RECOVERY WITH STABLE VITALS POST OPERATIVELY.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 16613071 ↗
• InjurySep 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 27MM 2700TFX VALVE, IMPLANTED IN AORTIC POSITION, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS, 1 MONTH DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11500A VALVE.

  Patient problems: Insufficient Information

  MAUDE report 15411820 ↗
• InjurySep 2, 2022Calcified; Degraded; Gradient Increase; Calcified; Degraded; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 2700TFX AORTIC VALVE IMPLANTED FOR 4 YEARS AND 11 MONTHS UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO STENOSIS. PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE PROCEDURE WAS PERFORMED SUCCESSFULLY WITH A 29MM 9600TFX TRANSCATHETER VALVE. PATIENT TOLERATED PROCEDURE WELL AND TRANSFERRED TO RECOVERY.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 15349858 ↗
• InjuryApr 20, 2022Perivalvular Leak; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Perivalvular Leak; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT A 27MM 2700TFX AORTIC VALVE, IMPLANTED FOR THREE YEARS, WAS EXPLANTED DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH A 25MM 3300TFX 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 14164269 ↗
• InjuryMar 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 2700TFX AORTIC VALVE, IMPLANTED IN THE PULMONIC POSITION FOR 5 YEARS AND 2 MONTHS, UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO AORTIC REGURGITATION. THE PROCEDURE WAS PERFORMED WITH AN EDWARDS TRANSCATHETER VALVE. NO OTHER DETAILS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13725856 ↗