CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS - AORTIC 2700TFX (REF 2700TFX21MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00690103177176), received between May 27, 2022 and Mar 19, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Calcified” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 2700TFX AORTIC VALVE WAS PLACED UNDER EVALUATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 11 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE TAVR WAS PERFORMED WITH A NON-EDWARDS VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE AND DISCHARGED ON POD #1.

  Patient problems: Dyspnea

  MAUDE report 21646635 ↗
• InjuryAug 28, 2024Calcified; Device Stenosis; Calcified; Device Stenosis

  IT WAS REPORTED A PATIENT WITH A 21MM 2700 AORTIC VALVE IMPLANTED FOR SEVEN (7) YEARS, TEN MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO CALCIFICATION AND STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE. THE TAVR WAS SUCCESSFULLY PERFORMED WITH A 23MM 9750TFX VALVE. THE PATIENT WAS TRANSFERRED TO THE CV-ICU FOR RECOVERY.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 20087760 ↗
• InjuryMay 9, 2024Gradient Increase; Gradient Increase

  IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY THAT A 21MM 2700TFX AORTIC VALVE, WAS EXPLANTED AFTER AN IMPLANT DURATION OF NINE (9) YEARS, ONE (1) MONTH DUE TO STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH, CHEST PAIN, AND FATIGUE. 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: Chest Pain; Dyspnea; Fatigue

  MAUDE report 19281933 ↗
• InjuryApr 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 2700TFX PERICARDIAL AORTIC VALVE WAS PLACED UNDER EVALUATION FOR VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF NINE (9) YEARS, FOUR (4) MONTHS DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 19215218 ↗
• InjuryAug 29, 2023Calcified; Insufficient Device Problem Information; Patient Device Interaction Problem; Calcified; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 21MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 1 MONTH DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 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 17646814 ↗
• InjuryMay 27, 2022Degraded; Gradient Increase; Patient-Device Incompatibility; Degraded; Gradient Increase; Patient-Device Incompatibility

  IT WAS REPORTED THAT THIS PATIENT WITH A 21MM AORTIC VALVE, IMPLANTED FOR SIX (6) YEARS AND ONE (1) MONTH, IS BEING EVALUATED FOR A REDO PROCEDURE WITH ROOT ENLARGEMENT DUE TO DETERIORATION, LEAFLET THICKENING, AND SEVERE STENOSIS. THE PATIENT PRESENTED WITH NYHA CLASS III. PER MEDICAL RECORDS PATIENT PROSTHESIS MISMATCH IS SUSPECTED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 14523507 ↗