CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS - AORTIC 2700TFX (REF 2700TFX27MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00690103177206), received between Jan 28, 2021 and Dec 10, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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.

• InjuryDec 10, 2024Intravalvular regurgitation; 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 NINE (9) YEARS, FIVE (5) MONTHS DUE TO AORTIC INSUFFICIENCY. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE TAVR WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Dyspnea

  MAUDE report 20894224 ↗
• InjuryMay 2, 2024Insufficient 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 NINE (9) YEARS, TWO (2) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A INSPIRIS VALVE.

  Patient problems: Insufficient Information

  MAUDE report 19231221 ↗
• InjuryApr 3, 2023Fluid/Blood Leak; Gradient Increase; Fluid/Blood Leak; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 2700TFX 27MM AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, SEVEN (7) MONTHS DUE TO AORTIC INSUFFICIENCY AND STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE. THE TAVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 26MM 9750TFX VALVE. THE PATIENT WAS STABLE AT THE END OF THE PROCEDURE AND TRANSFERRED TO RECOVERY (ICU).

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 16668622 ↗
• InjuryJun 3, 2022Calcified; Degraded; Fluid/Blood Leak; Gradient Increase; Difficult to Open or Close; Insufficient Device Problem Information; Calcified; Degraded; 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. THROUGH IMPLANT PATIENT REGISTRY, IT WAS REPORTED THAT A PATIENT WITH A 27 MM 2700TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 9 MONTHS DUE TO UNKNOWN REASON. THE TAVR WAS PERFORMED WITH A 26 MM 9750TFX TRANSCATHETER VALVE.

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

  MAUDE report 14595504 ↗
• InjuryJan 28, 2021Fluid/Blood Leak; Gradient Increase; Fluid/Blood Leak; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 2700TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, FOUR (4) MONTHS DUE TO SEVERE AORTIC STENOSIS AND AORTIC REGURGITATION. THE TAVR WAS PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSPORTED TO THE CARDIAC POST-ANESTHESIA CARE UNIT IN SATISFACTORY CONDITION. THE PATIENT WAS DISCHARGED HOME ON POD #1 IN STABLE CONDITION.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 11246052 ↗