CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis 2700TFX (REF 2700TFX23MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00690103194036), received between Oct 12, 2021 and Aug 14, 2026 — classified as 29 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (15 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  It was learned through Implant Patient Registry that a patient with a 23mm 2700TFX aortic valve was explanted after an implant duration of 5 years, 1 months due to unknown reasons. The explanted valve was replaced with a 23mm 11500A 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: Endocarditis; Insufficient Information

  MAUDE report 50261880 ↗
• InjuryJan 5, 2026Device Stenosis

  IT WAS REPORTED THAT A 23MM 2700TFX AORTIC VALVE IN AORTIC POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 7 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED IN HEART FAILURE REQUIRING HOSPITALIZATION AND TREATMENT. TAVR WAS COMPLETED WITH A 23MM 9755RSL TRANSCATHETER VALVE AND PATIENT WAS TRANSFERRED TO ICU IN STABLE CONDITION. PER MEDICAL RECORDS, PATIENT WAS ADMITTED FOR VALVE-RELATED HEART FAILURE REQUIRING ICU ADMISSION AND FURTHER MANAGEMENT. PATIENT REFUSED SAVR AND UNDERWENT TAVR PROCEDURE WITH LOW CARDIAC OUTPUT REQUIRING SHORT EPISODE OF CHEST COMPRESSIONS AND DISCHARGED ON POD3. PATIENT UNDERWENT TF-VIV TAVR WITH # 23 S3 POST-DILATED WITH 22 MM TRUE BALLOON.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23970215 ↗
• InjuryDec 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 23MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS, 11 MONTHS TO REPAIR AORTIC DISSECTION. THE PATIENT PRESENTED WITH CHEST PAIN. THE EXPLANTED DEVICE WAS REPLACED WITH A 25MM 11060A AORTIC VALVED CONDUIT. THE PATIENT WAS DISCHARGED ON POD #8.

  Patient problems: Insufficient Information

  MAUDE report 23851362 ↗
• InjurySep 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 23MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF SIX (6) YEARS, AND THREE (3) MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 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 22994877 ↗
• InjuryAug 11, 2025Calcified; Degraded; Patient Device Interaction Problem; Calcified; Degraded; Patient Device Interaction Problem

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS RECEIVED THAT A 23MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 11 MONTHS DUE TO DEGENERATION, CALCIFICATION, PANNUS AND SEVERE AORTIC STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM PERIMOUNT VALVE. THE PATIENT WAS DISCHARGED ON POD# 7. PER MEDICAL RECORDS, THE PATIENT UNDERWENT REDO-AVR WITH 25MM PERIMOUNT VALVE, MV REPAIR WITH NON-EDWARDS RING, REDO-TV REPAIR WITH 26MM MC3 ANNULOPLASTY RING, CABG AND MAZE PROCEDURE. INTRAOPERATIVELY, PROSTHETIC AV WITH SIGNS OF STRUCTURAL DEGENERATION, CALCIFIED LEAFLETS AND PANNUS ON SEWING RING. POSTOP TEE SHOWED GOOD FUNCTION OF ALL VALVES. 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 RE

  Patient problems: Dyspnea

  MAUDE report 22779181 ↗
• InjuryJul 13, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS, 4 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 11500A INSPIRIS RESILIA 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: Endocarditis; Insufficient Information

  MAUDE report 22491098 ↗
• InjuryJul 8, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 2700TFX AORTIC VALVE, IMPLANTED IN THE PULMONIC POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 9 MONTHS DUE TO REGURGITATION AND STENOSIS. PATIENT PRESENTED WITH FEET SWELLING. THE PROCEDURE WAS PERFORMED WITH A 23MM 9600TFX TRANSCATHETER VALVE. PATIENT WAS STABLE POST PROCEDURE AND WAS DISCHARGED ON POD#1. THIS IS A 19-YEAR-OLD MALE PATIENT.

  Patient problems: Insufficient Information; Swelling/ Edema

  MAUDE report 22436101 ↗
• InjuryApr 21, 2025Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS THAT A 23MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS, 2 MONTHS DUE TO CALCIFICATION, DEGENERATION AND STENOSIS. PATIENT PRESENTED WITH DYSPNEA ON EXERTION AND CHEST DISCOMFORT. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A INIPRIS RELISA AORTIC VALVE. PATIENT WAS STABLE POST-PROCEDURE, TRANSFERRED TO ICU AND WAS DISCHARGED ON POD#7. PER MEDICAL RECORDS, TEE DEMONSTRATED THICKENED AND RESTRICTED LEAFLETS CONSISTENT WITH DEGENERATION AND STENOSIS. HEAVY CALCIFICATION WAS NOTED UPON INTRAOPERATIVE INSPECTION. PATIENT UNDERWENT REDO AVR WITH CABG. THE PATIENT WAS WEANED FROM CPB WITHOUT COMPLICATION. PATIENT WAS RETURNED TO ICIU IN SERIOUS BUT STABLE CONDITION. THIS IS A 65-YEAR-OLD MALE PATENT. 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 T

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 21877822 ↗
• InjuryMar 21, 2025Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 2700TFX AORTIC VALVE, IMPLANTED IN THE PULMONIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, 11 MONTHS DUE TO INSUFFICIENCY. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE SUCCESSFULLY WITHOUT COMPLICATION.

  Patient problems: Insufficient Information

  MAUDE report 21665542 ↗
• InjuryMar 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 2700TFX PERICARDIAL AORTIC VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF THREE (3) YEARS, FIVE (5) MONTHS DUE TO UNKNOWN REASONS. THE TAVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 21608432 ↗
• InjuryJan 6, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 2700TFX AORTIC VALVE, IMPLANTED IN THE MITRAL POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, FIVE (5) MONTHS DUE TO SEVERE MITRAL STENOSIS AND MITRAL REGURGITATION. THE PATIENT PRESENTED WITH SYMPTOMS OF HAS NYHA II-III (HEART FAILURE), SHORTNESS OF BREATH AND FATIGUE. PER FCS, PHYSICIAN STATED THAT SURGICAL VALVE DID FAIL PREMATURELY. THE PROCEDURE WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED ON POD#2.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 21078717 ↗
• InjurySep 21, 2024Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 2700 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 YEARS, 6 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 3300TFX 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: Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 20275012 ↗
• InjuryAug 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY THAT A 2700TFX 23MM AORTIC VALVE WAS EXPLANTED AND REPLACED WITH A 11500A 25MM 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 20053600 ↗
• InjuryAug 15, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A 23MM 2700TFX VALVE IN THE AORTIC POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 4 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE AND DYSPNEA. THE TAVR WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 19993875 ↗
• InjuryAug 8, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A 23MM 2700TFX VALVE IN THE PULMONARY POSITION UNDERWENT A VALVE-IN-VALVE AFTER AN IMPLANT DURATION OF 5 YEARS, 5 MONTHS PROCEDURE DUE TO STENOSIS. THE PATIENT WAS ASYMPTOMATIC. THE TPVR WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939757 ↗
• InjuryApr 23, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED AND LEARNED THROUGH INVESTIGATION THAT A PATIENT WITH A 23MM 2700TFX PERIMOUNT AORTIC VALVE IN AORTIC POSITION UNDERWENT A VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SIX (6) YEARS, TWO (2) MONTHS DUE TO STENOSIS AND REGURGITATION. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND DIZZINESS. TAVR WAS COMPLETED WITH A 23MM 9755RSL TRANSCATHETER VALVE AND PATIENT WAS DISCHARGED HOME IN STABLE CONDITION.

  Patient problems: Dizziness; Dyspnea; Insufficient Information

  MAUDE report 19161192 ↗
• InjuryApr 18, 2024Microbial Contamination of Device; Insufficient Device Problem Information; Microbial Contamination of Device; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORD THAT A 23MM 2700TFX AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF FOUR (4) YEARS, 7 MONTHS DUE TO INFECTIVE E. FAECALIS ENDOCARDITIS. PATIENT WAS PRESENTED FEVER AND WEAKNESS. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A INSPIRIS RESILIA AORTIC VALVE AND PATIENT WAS DISCHARGED TO HOME IN STABLE CONDITION ON POD # 7.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 19131550 ↗
• InjurySep 12, 2023Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 2700TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS DUE TO SEVERE AORTIC STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE TAVR WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE. THE PROCEDURE WAS SUCCESSFUL, AND THE PATIENT WAS SENT TO RECOVERY IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Dyspnea

  MAUDE report 17732537 ↗
• InjuryAug 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED THAT A 23MM 2700TFX VALVE, IMPLANTED IN AORTIC POSITION, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS, 4 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A VALVE.

  Patient problems: Insufficient Information

  MAUDE report 17485531 ↗
• InjuryJul 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 2700TFX VALVE IMPLANTED IN THE PULMONIC POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS AND 11 MONTHS DUE TO UNKNOWN REASONS. THE TPVR PROCEDURE WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 17328184 ↗
• InjuryDec 14, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY, IT WAS LEARNED THAT A 23MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS, 3 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11500A VALVE. THE PATIENT UNDERWENT A REDO MVR PROCEDURE WITHIN THE SAME SURGERY. THE PATIENT WAS IN RECOVERY POST PROCEDURE. THE IMPLANTATION DATA CARD INDICATED THAT THE DEVICE EXPLANT WAS NOT DUE TO DEFICIENCY OF THE ORIGINAL DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 15977758 ↗
• InjuryOct 10, 2022Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT THIS PATIENT WITH A 2700TFX 23MM AORTIC VALVE IMPLANTED FOR FIVE (5) YEARS AND 11 MONTHS, IS BEING EVALUATED FOR VALVE-IN-VALVE PROCEDURES DUE TO STENOSIS.

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

  MAUDE report 15572794 ↗
• InjuryAug 23, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 23MM 2700TFX VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 YEARS, 2 MONTHS DUE TO PVL. THE PATIENT UNDERWENT BENTALL PROCEDURE TO TREAT AORTIC ANEURYSM. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 11500A VALVE. THE PATIENT WAS DISCHARGED HOME ON POD#9. THE PATIENT IS A 57-YEARS-OLD FEMALE WITH A HISTORY OF HYPERTENSION, HYPERLIPIDEMIA, ASTHMA, DIABETES MELLITUS, ATRIAL FIBRILLATION ON ANTICOAGULATION, COMPLETE HEART BLOCK S/P PPM, VOCAL CORD DYSFUNCTION, HYPOTHYROIDISM, ENDOCARDITIS STREP VIRIDANS S/P REDO AVR/DEBRIDEMENT OF AORTIC ANNULUS DRAINAGE OF ABSCESS AND PLACEMENT OF A #23 MM BOVINE PERICARDIAL PATCH (5/7/2019), LIGATION OF CELIAC ARTERY PSEUDOANEURYSM (2019) AND DILATED ASCENDING AORTA FOUND TO HAVE PSEUDOANEURYSM OF ASCENDING AORTA.

  Patient problems: Insufficient Information

  MAUDE report 15277599 ↗
• InjuryJul 1, 2022Fluid/Blood Leak; Gradient Increase; Insufficient Device Problem Information; Fluid/Blood Leak; Gradient Increase; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PATIENT WITH A 2700TFX 23MM AORTIC VALVE, IMPLANTED FOR THREE (3) YEARS AND FIVE (5) MONTHS, IS BEING EVALUATED FOR A VALVE-IN-VALVE PROCEDURE DUE TO UNKNOWN REASONS.

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

  MAUDE report 14886967 ↗
• InjuryJun 24, 2022Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A 23 MM PERICARDIAL AORTIC VALVE WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE VIA THE AXILLARY ARTERY AFTER AN IMPLANT DURATION OF 6 YEARS, 9 MONTHS DUE TO SEVERE STENOSIS. THE PATIENT PRESENTED WITH CHF. A 23 MM TRANSCATHETER VALVE WAS IMPLANTED. THE PATIENT WAS DISCHARGED ON POD #3. PER REP, PHYSICIAN BELIEVES SURGICAL VALVE FAILED PREMATURELY.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 14807397 ↗