CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS - AORTIC 2700TFX (REF 2700TFX29MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00690103177213), received between Aug 5, 2022 and Jul 12, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Stenosis” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A 29MM 2700TFX VALVE IN THE AORTIC POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 10 MONTHS DUE TO SEVERE STENOSIS. THE PATIENT PRESENTED WITH NYHA CLASS 4 SYMPTOMS. THE TAVR WAS PERFORMED WITH A 29MM 9600TFX TRANSCATHETER VALVE. THE PATIENT WAS DISCHARGED HOME ON POD #1.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 19731545 ↗
• InjuryMar 18, 2024Fluid/Blood Leak; Device Stenosis; Fluid/Blood Leak; Device Stenosis

  IT WAS REPORTED THAT PATIENT WITH 29MM 2700TFX AORTIC VALVE UNDERWENT VALVE-IN-VALVE PROCEDURE AFTER IMPLANT DURATION OF EIGHT (8) YEARS, 4 DAYS DUE TO STENOSIS AND AORTIC INSUFFICIENCY. PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE PROCEDURE WAS PERFORMED WITH 29MM 9600TFX TRANSCATHETER VALVE.

  Patient problems: Dyspnea

  MAUDE report 18919542 ↗
• InjuryMay 22, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED FROM IMPLANT PATIENT REGISTRY THAT A MODEL 2700TFX 29MM AORTIC VALVE WAS EXPLANTED AND REPLACED WITH A 11060A 25MM VALVE AFTER AN IMPLANT DURATION OF 7 YEARS, 4 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: Aneurysm; Chest Pain; Insufficient Information

  MAUDE report 16981777 ↗
• InjurySep 24, 2022Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 2700TFX PERICARDIAL AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SIX (6) YEARS, SEVEN (7) MONTHS DUE TO AORTIC STENOSIS. THE TAVR PROCEDURE WAS PERFORMED WITH A 29MM 9600TFX TRANSCATHETER VALVE. THE PATIENT WAS NOTED TO HAVE BEEN DISCHARGED POST PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 15477712 ↗
• InjuryAug 5, 2022Perivalvular Leak; Perivalvular Leak

  THROUGH IMPLANT PATIENT REGISTRY, IT WAS LEARNED THAT A 29MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN UNKNOWN DURATION DUE TO EARLY PARAVALVULAR AORTIC REGURGITATION. PER THE INFORMATION RECEIVED, THE PATIENT UNDERWENT THREE (3) AORTIC VALVE REPLACEMENTS IN 2015, THE THIRD REPLACEMENT VALVE WAS A NON-EDWARDS MECHANICAL 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 15175733 ↗