CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS - AORTIC 3000 (REF 300023MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00690103162257), received between Apr 1, 2021 and Oct 22, 2025 — classified as 26 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (12 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 26 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 3000 AORTIC VALVE HAS BEEN PLACED UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 7 MONTHS DUE TO STENOSIS (MG 40.9 MMHG). THE PATIENT PRESENTED WITH CHEST PAIN, PALPITATIONS AND DIZZINESS.

  Patient problems: Chest Pain; Dizziness

  MAUDE report 23360228 ↗
• InjurySep 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 23MM 3000 PERICARDIAL AORTIC VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF NINE (9) YEARS, TWO (2) MONTHS DUE TO UNKNOWN REASONS. THE TAVR PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER 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 22980527 ↗
• InjuryAug 21, 2025Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 3000 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS AND 3 MONTHS DUE TO CALCIFICATION, DEGENERATION, AND STENOSIS. THE PATIENT WAS PRESENTED WITH FATIGUE. THE VALVE WAS REPLACED WITH A 23MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Fatigue

  MAUDE report 22868658 ↗
• InjuryJun 17, 2025Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 3000 AORTIC VALVE, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 7 MONTHS DUE TO UNKNOWN REASON. THE TAVR WAS SUCCESSFULLY PERFORMED WITH A 23MM 9755RSL VALVE.

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

  MAUDE report 22235115 ↗
• InjuryMay 23, 2025Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 3000 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 2 MONTHS DUE TO CALCIFICATION, DEGENERATION, AND SEVERE STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE. THE TAVR WAS SUCCESSFULLY PERFORMED WITH A 23MM 9755RSL VALVE. THE PATIENT WAS IN STABLE CONDITION POST-PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22079424 ↗
• InjuryMay 16, 2025Calcified; Calcified

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 23MM 3000 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 9 MONTHS DUE TO DEGENERATION, HEAVY CALCIFICATION, WITH SEVERE STENOSIS AND RESTRICTED OPENING. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A VALVE. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH CHF CHRONIC DIASTOLIC. THE PATIENT UNDERWENT REDO - AVR WITH A 23MM INSPIRIS VALVE. POST BYPASS TEE A WELL-SEATED PROSTHETIC AV WITH NO PVL. THE PATIENT WAS TRANSPORTED IN ICU IN CRITICAL BUT STABLE CONDITION. THE PATIENT WAS DISCHARGED HOME WITH OUTPATIENT PT ON POD#4. 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

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22038623 ↗
• InjuryFeb 11, 2025Calcified; 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 23MM 3000 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 6 MONTHS DUE TO UNKNOWN REASONS. 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: Insufficient Information

  MAUDE report 21357267 ↗
• InjuryFeb 4, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 3000 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 4 MONTHS DUE TO STENOSIS AND REGURGITATION. PATIENT PRESENTED WITH HEAT FAILURE. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 11500A INSPIRIS RELISA AORTIC VALVE. PATIENT WAS DISCHARGED ON POD#25 THIS IS A 60-YEAR-OLD MALE PATIENT. 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 21300939 ↗
• InjuryJan 21, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 3000 AORTIC VALVE, HAS BEEN PLACED UNDER EVALUATION A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, EIGHT (8) MONTHS DUE TO AORTIC STENOSIS. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE AND SHORTNESS OF BREATH.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 21198361 ↗
• InjuryNov 11, 2024Device Stenosis; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 23MM 3000 AORTIC VALVE IN PULMONIC POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, TEN (10) MONTHS DUE TO STENOSIS AND REGURGITATION. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH, FATIGUE, AND ACTIVITY INTOLERANCE. TPVR WAS COMPLETED WITH A 23MM 9750TFX TRANSCATHETER VALVE AND PATIENT WAS STABLE AT THE END OF THE 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: Dyspnea; Fatigue

  MAUDE report 20649913 ↗
• InjuryOct 11, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A 23MM 3000 AORTIC VALVE IN AORTIC POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 7 MONTHS DUE TO STENOSIS AND REGURGITATION. TAVR WAS COMPLETED WITH A 23MM 9755RSL TRANSCATHETER VALVE WITHOUT ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 20427888 ↗
• InjuryJun 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED A 23MM 3000 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF SIX (6) YEARS, 11 MONTHS, DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH A 25MM 11060A AORTIC VALVED CONDUIT. PATIENT POST-OPERATIVE STATUS NOTED AS IN RECOVERY. 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 19552763 ↗
• InjuryJun 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 23MM 3000 PERICARDIAL AORTIC VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, FOUR (4) MONTHS DUE TO UNKNOWN REASONS. THE TAVR PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 19459922 ↗
• InjuryMar 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 3000 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS, 2 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 26MM 11060A VALVE CONDUIT. 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 18859606 ↗
• InjuryFeb 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A PATIENT WITH A 23MM MAGNA AORTIC VALVE IMPLANTED FOR APPROXIMATELY SEVEN (7) YEARS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO UNKNOWN REASONS. TAVR WAS SUCCESSFULLY PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 18628118 ↗
• InjuryNov 14, 2023Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 23MM 3000 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 3 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 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: Insufficient Information

  MAUDE report 18136669 ↗
• InjuryOct 5, 2023Fluid/Blood Leak; Gradient Increase; Fluid/Blood Leak; Gradient Increase

  IT WAS REPORTED THAT A 23MM 3000 AORTIC VALVE WAS DISABLED AFTER AN IMPLANT DURATION OF SEVEN YEARS, FOUR MONTHS DUE TO STENOSIS AND REGURGITATION. THE PATIENT PRESENTED WITH HEART FAILURE. THE TAVR WAS COMPLETED WITH A 26MM 9755RSL TRANSCATHETER VALVE AND PATIENT WAS IN STABLE CONDITION AT THE END OF THE PROCEDURE.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure; Syncope/Fainting

  MAUDE report 17878197 ↗
• InjuryJun 26, 2023Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 3000 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 4 MONTHS DUE TO SEVERE STENOSIS. THE TAVR WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS STABLE AND TRANSFERRED TO THE PACU POST PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 17204539 ↗
• InjuryJun 16, 2023Degraded; Gradient Increase; Insufficient Device Problem Information; Degraded; Gradient Increase; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 3000 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 YEARS, 3 MONTHS DUE TO SEVERE STENOSIS DUE TO DEGENERATION. THE PATIENT PRESENTED WITH ACUTE CHF. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A VALVE. PER MEDICAL RECORDS: THE PATIENT HAD SEVERE PULMONARY HTN AT THE START OF THE PROCEDURE. THE PATIENT UNDERWENT REDO AVR WITH A 23MM 11500A VALVE, POST CPB TEE SHOWED NO PVL AND GOOD LEAFLET MOTION, BIVENTRICULAR FUNCTION WAS BASELINE. THE PATIENT WAS DISCHARGED ON POD #12.

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

  MAUDE report 17148211 ↗
• InjuryJun 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 3000 AORTIC VALVE UNDERWENT A VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN YEARS AND 11 MONTHS DUE TO UNKNOWN REASONS. THE TAVR PROCEDURE WAS COMPLETED WITH A 26MM 9755RSL 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 17117720 ↗
• InjuryMay 26, 2023Calcified; Degraded; Calcified; Degraded

  IT WAS LEARNED VIA THE IMPLANT PATIENT REGISTRY THAT A 3000 23MM BIOPROSTHETIC AORTIC VALVE, IMPLANTED FOR SIX (6) YEARS AND EIGHT (8) MONTHS, WAS EXPLANTED DUE TO DEGENERATION SECONDARY TO CALCIFICATION. THE PATIENT INITIALLY PRESENTED WITH SHORTNESS OF BREATH AND CHEST PAIN. THE EXPLANTED DEVICE WAS REPLACED WITH AN 11500A 23MM INSPIRIS RESILIA VALVE. THE PATIENT WAS NOTED TO BE IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Angina; Dyspnea

  MAUDE report 17014942 ↗
• InjuryApr 29, 2022Degraded; Fluid/Blood Leak; Gradient Increase; Degraded; Fluid/Blood Leak; Gradient Increase

  EDWARDS RECEIVED INFORMATION A PATIENT WITH A 23MM 3000 AORTIC VALVE IMPLANTED SEVEN (7) YEARS, TWO (2) MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO SEVERE STRUCTURAL VALVE DEGENERATION WITH MIXED SEVERE AORTIC STENOSIS AND INSUFFICIENCY. SURGICAL VALVE PREMATURELY FAILED. PATIENT PRESENTED WITH EXERTIONAL CHEST PAIN. RECORDS NOTED PATIENT HAS NO SYMPTOMS OF HEART FAILURE AND THAT THE CHEST PAIN COULD BE RELATED TO THE VALVE OR TO THE CORONARY ARTERY DISEASE. A 23MM 9750TFX TRANSCATHETER VALVE WAS SUCCESSFULLY IMPLANTED INSIDE THE 23MM VALVE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND WAS TRANSFERRED TO THE POST ANESTHESIA CARE UNIT IN STABLE CONDITION.

  Patient problems: Chest Pain

  MAUDE report 14251573 ↗
• InjuryApr 11, 2022Calcified; Degraded; Gradient Increase; Calcified; Degraded; Gradient Increase

  EDWARDS RECEIVED NOTIFICATION FROM A PATIENT THAT A 3000 23MM AORTIC VALVE IS BEING EVALUATED FOR A REDO-AVR PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 4 MONTHS DUE TO CALCIFICATION, DETERIORATION, AND STENOSIS. THE PATIENT PRESENTED WITH SOB AND IRREGULAR HEARTBEAT.

  Patient problems: Arrhythmia

  MAUDE report 14076569 ↗
• InjuryFeb 18, 2022Calcified; Fluid/Blood Leak; Gradient Increase; Difficult to Open or Close; Calcified; Fluid/Blood Leak; Gradient Increase; Difficult to Open or Close

  IT WAS REPORTED THAT THIS PATIENT WITH A 3000 23MM AORTIC VALVE, IMPLANTED FOR SIX (6) YEARS AND TWO (2) MONTHS, UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO SEVERELY CALCIFIED LEAFLETS, REDUCED LEAFLET EXCURSION, WITH SYMPTOMATIC SEVERE STENOSIS AND MODERATE REGURGITATION. PATIENT PRESENTED WITH SHORTNESS OF BREATH WITH EXERTION, AND WORSENING DIZZINESS WITH ACUTE ON CHRONIC SYSTOLIC HEART FAILURE NYHA CLASS ILL. THE PROCEDURE WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE. PATIENT WAS DISCHARGE ON POD#6 PER MEDICAL RECORDS: AORTIC STENOSIS STAGE: STAGE D - SYMPTOMATIC, SEVERE AS. STAGE D2, PATIENTS HAVE SYMPTOMATIC SEVERE LOW-FLOW/ LOW-GRADIENT AS WITH REDUCED LVEF (LVEF <50 PERCENT).

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 13564080 ↗
• InjuryMay 26, 2021Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 3000 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF NINE (9) YEARS, 10 MONTHS DUE TO CRITICAL AORTIC STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE WITH PRESERVED EF. A SUCCESSFUL TAVR WAS PERFORMED WITH A 23MM 9750TFX VALVE. THE PATIENT WAS DISCHARGED IN STABLE CONDITION TO REHAB FACILITY ON POD # 6.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 11882331 ↗