CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTIC 2800TFX (REF 2800TFX25MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00690103177251), received between Oct 4, 2021 and Aug 26, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Calcified” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2024Thickening of Material; Thickening of Material

  EDWARDS RECEIVED NOTIFICATION THAT A PATIENT WITH A 2800TFX25 VALVE IMPLANTED IN AORTIC POSITION UNDERWENT A VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF NINE (9) YEARS AND ONE (1) MONTH DUE TO LEAFLET THICKENING AND STIFF LEAFLET MOVEMENT LEADING TO SEVERE REGURGITATION AND MODERATE STENOSIS OBSERVED ON CARDIAC ULTRASOUND. DURING TELEPHONE FOLLOW-UP WITH THE PATIENT, IT WAS LEARNED THAT THE PATIENT WAS HOSPITALIZED FOR CHEST TIGHTNESS AND ASTHMA FOUR (4) DAYS BEFORE REINTERVENTION. A 29MM NON EDWARDS TRANSCATHETER VALVE WAS SUCCESSFULLY IMPLANTED WITHIN THE EDWARDS SURGICAL VALVE CONCOMITANTLY WITH CORONARY ARTERY GRAFT (CAG). POSTOPERATIVE ULTRASOUND SHOWED THAT THE TRANSCATHETER VALVE FUNCTIONED NORMALLY. DURING THE HOSPITALIZATION, ANTIPLATELET, LIPID REGULATION AND PLAQUE STABILIZATION, DIURESIS, IMPROVEMENT OF CARDIAC FUNCTION, HYPOGLYCEMIA AND SYMPTOMATIC SUPPORTIVE TREATMENT WERE GIVEN. THE PATIENT WAS DISCHARGED ON POSTOPERATIVE DAY (POD)# 4.

  Patient problems: Asthma; Chest Pain

  MAUDE report 20062034 ↗
• InjuryMay 16, 2024Calcified; Calcified

  IT WAS LEARNED THROUGH PATIENT SUPPORT CENTER AND MEDICAL RECORDS, A PATIENT WITH A 25MM 2800TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SIX (6) YEARS, NINE (9) MONTHS, DUE TO CALCIFICATION, SEVERE MITRAL REGURGITATION AND SEVERE STENOSIS. PATIENT PRESENTED WITH V. TACH CARDIAC ARREST, SEVERE CARDIOMYOPATHY, AND ACUTE CONGESTIVE HEART FAILURE. TAVR WAS PERFORMED WITH A 29MM NON-EDWARDS TRANSCATHETER VALVE. PATIENT WAS EXTUBATED SUCCESSFULLY IN OR AND TRANSFERRED TO MICU. PATIENT WAS DISCHARGED ON POD# 3. PATIENT MADE NO ALLEGATION AGAINST THE 2800TFX VALVE. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH V. TACH CARDIAC ARREST, SEVERE CARDIOMYOPATHY, AND ACUTE CONGESTIVE HEART FAILURE. TAVR WAS PERFORMED WITH A 29MM NON-EDWARDS TRANSCATHETER VALVE. PATIENT WAS EXTUBATED SUCCESSFULLY IN OR AND TRANSFERRED TO MICU. PATIENT WAS DISCHARGED ON POD# 3.

  Patient problems: Cardiac Arrest; Heart Failure/Congestive Heart Failure

  MAUDE report 19332857 ↗
• InjuryJan 4, 2023Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE IMPLANT PATIENT REGISTRY THAT A 25MM BIOPROSTHETIC AORTIC VALVE, IMPLANTED FOR SEVEN (7) YEARS AND SIX (6) MONTHS, WAS EXPLANTED DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH A 27MM 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: Dyspnea; Insufficient Information

  MAUDE report 16097348 ↗
• InjuryOct 4, 2021Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 2800TFX PERICARDIAL VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF TWO (2) YEARS, FIVE (5) MONTHS DUE TO STENOSIS. THE TAVR WAS PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE. THE PATIENT WAS REPORTED TO BE IN A STABLE CONDITION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12572874 ↗