CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS - AORTIC 2700TFX (REF 2700TFX25MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00690103177190), received between Mar 1, 2021 and Feb 18, 2025 — classified as 15 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 2700TFX AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 3 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 11500A AORTIC VALVE. REPORTEDLY, THE PATIENT WAS IN RECOVERY POST OPERATIVE. CONCOMITANTLY, PATIENT HAD AN MVR PROCEDURE ON THE SAME DAY. 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 21397299 ↗
• InjuryOct 11, 2024Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 2700TFX PERICARDIAL AORTIC VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF NINE (9) YEARS, THREE (3) MONTHS DUE TO AORTIC STENOSIS WITH THICKENED LEAFLETS CAUSING DECREASED MOBILITY. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND HEART FAILURE. THE TAVR PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS STABLE POST PROCEDURE AND DISCHARGED HOME ON POD #1.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 20434259 ↗
• InjuryJul 23, 2024Calcified; Calcified

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND LATER THROUGH INVESTIGATION THAT A 25MM 2700TFX AORTIC VALVE IMPLANTED EIGHT (8) YEARS, EIGHT (8) MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO DEGENERATION, CALCIFICATION, AND STENOSIS. PATIENT PRESENTED WITH HEART FAILURE, SHORTNESS OF BREATH, AND CHEST PAIN. TAVR WAS PERFORMED WITH 26MM 9755RSL TRANSCATHETER VALVE. PATIENT WAS STABLE AT THE END OF THE PROCEDURE AND HAS BEEN DISCHARGED HOME. 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

  MAUDE report 19811472 ↗
• InjuryJul 18, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A MODEL 2700TFX 25MM PERICARDIAL AORTIC VALVE WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS DUE TO STENOSIS AND REGURGITATION. THE PATIENT PRESENTED WITH INCREASING DOE, WEIGHT GAIN, AND BACK PAIN. A 9750TFX 26MM TRANSCATHETER VALVE WAS IMPLANTED SUCCESSFULLY.

  Patient problems: Dyspnea

  MAUDE report 19772016 ↗
• InjuryApr 12, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A 25MM 2700TFX VALVE IN THE AORTIC POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 1 MONTH DUE TO STENOSIS. THE TAVR WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 19098698 ↗
• InjuryMar 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY THAT A 25MM AORTIC VALVE WAS EXPLANTED AND REPLACED WITH A 25MM VALVE AFTER AN IMPLANT DURATION OF 8 YEARS, 8 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 18974666 ↗
• InjuryMar 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED THAT A 25MM 2700TFX VALVE IN THE AORTIC POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 5 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A VALVE.

  Patient problems: Insufficient Information

  MAUDE report 18946852 ↗
• InjuryJan 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED A 25MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF NINE (9) YEARS, DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH A 25MM 11500A AORTIC 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 18588610 ↗
• InjurySep 1, 2023Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 2700TFX AORTIC VALVE HAS BEEN PLACED UNDER EVALUATION/CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF APPROXIMATELY 8 YEARS, 3 MONTHS DUE TO AORTIC INSUFFICIENCY. THE PATIENT PRESENTED WITH EXERTIONAL DYSPNEA AND CHEST PAIN.

  Patient problems: Chest Pain; Dyspnea; Insufficient Information

  MAUDE report 17670765 ↗
• InjuryJul 21, 2023Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  IT WAS REPORTED, THAT A PATIENT WITH A 25MM 2700TFX AORTIC VALVE. UNDERWENT A VALVE-IN-VALVE PROCEDURE, AFTER AN IMPLANT DURATION OF 7 YEARS, 9 MONTHS, DUE TO STENOSIS. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. THE VALVE WAS IMPLANTED SUCCESSFULLY.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 17374904 ↗
• InjuryJun 21, 2023Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A MODEL 2700TFX 25MM PERICARDIAL VALVE IN THE PULMONIC POSITION WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 8 MONTHS DUE TO STENOSIS. A 9600TFX 26MM TRANSCATHETER VALVE WAS SUCCESSFULLY IMPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 17176322 ↗
• InjuryMay 19, 2023Fluid/Blood Leak; Gradient Increase; Fluid/Blood Leak; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 2700TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 1 MONTH DUE TO AORTIC STENOSIS AND AORTIC INSUFFICIENCY. THE PATIENT PRESENTED WITH HEART FAILURE, SHORTNESS OF BREATH, CHEST PAIN AND DIZZINESS. THE TAVR WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. THE PROCEDURE WAS SUCCESSFUL.

  Patient problems: Chest Pain; Dizziness; Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 16962171 ↗
• InjuryDec 1, 2022Calcified; Degraded; Gradient Increase; Calcified; Degraded; Gradient Increase

  IT WAS LEARNED FROM IMPLANT PATIENT REGISTRY THAT A 25MM AORTIC VALVE WAS EXPLANTED AND REPLACED WITH A 27MM VALVE AFTER AN IMPLANT DURATION OF 6 YEARS, 1 MONTH DUE TO CALCIFICATION, DEGENERATION, AND STENOSIS. THE PATIENT PRESENTED WITH DIZZINESS. THE PATIENT WAS IN RECOVERY. 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: Dizziness

  MAUDE report 15896460 ↗
• InjurySep 12, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 25MM PERICARDIAL AORTIC VALVE WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 9 MONTHS DUE TO UNKNOWN REASONS. A 26MM TRANSCATHETER VALVE WAS IMPLANTED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 15401661 ↗
• InjuryMar 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 2700TFX AORTIC PERICARDIAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF APPROXIMATELY 18 YEARS, FIVE (5) MONTHS DUE TO AORTIC STENOSIS, AORTIC REGURGITATION, AND PERIVALVULAR LEAK (PVL). THE TAVR WAS PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE. THERE WAS NO INDICATION FROM THE PHYSICIAN THAT SURGICAL VALVE PREMATURELY FAILED OR MALFUNCTIONED.

  Patient problems: Insufficient Information

  MAUDE report 11393511 ↗