CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis 2700TFX (REF 2700TFX25MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00690103194043), received between Feb 5, 2021 and Sep 18, 2026 — classified as 55 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (30 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 55 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50831464 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 1 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11060A VALVED 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: Endocarditis; Insufficient Information

  MAUDE report 24651333 ↗
• InjuryJan 26, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS, 8 MONTHS DUE TO UNKNOWN REASONS. 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 24182819 ↗
• InjuryDec 2, 2025Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 2700TFX AORTIC VALVE UNDERWENT EMERGENCY VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 5 MONTHS DUE TO SEVERE CALCIFICATION AND DEGENERATION. THE PATIENT PRESENTED WITH ACUTE HEART FAILURE. TAVR WAS SUCCESSFULLY PERFORMED WITH A 26MM 9755RSL VALVE. THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION POST-PROCEDURE AND DISCHARGED ON POD #3. PER MEDICAL RECORDS, PATIENT PRESENTED IN THE ER WITH CHEST PAIN/NSTEMI UNDERWENT LHC. TEE SHOWED SEVERE CALCIFICATION AND DEGENERATION OF THE BIOPROSTHETIC AORTIC VALVE WITH SEVERE STENOSIS, MG 50MMHG AND SEVERE TRANSVALVULAR REGURGITATION. THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND UNDERWENT EMERGENT VIV.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23701021 ↗
• InjuryOct 29, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 25MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS, DUE TO STENOSIS. THE PATIENT PRESENTED WITH SYNCOPE. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11500A VALVE. THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION POST PROCEDURE AND DISCHARGED ON POD #8.

  Patient problems: Insufficient Information; Syncope/Fainting

  MAUDE report 23416023 ↗
• InjurySep 5, 2025Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 2700TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 5 MONTHS DUE TO UNKNOWN REASON. THE PROCEDURE WAS PERFORMED SUCCESSFULLY WITH A 26MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS IN RECOVERY POST PROCEDURE.

  Patient problems: Fatigue; Insufficient Information

  MAUDE report 22986606 ↗
• InjuryAug 25, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 2700TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 11 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SOB. THE PROCEDURE WAS PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE. THE PATIENT TRANSFERRED TO ICU IN STABLE CONDITION.

  Patient problems: Dyspnea

  MAUDE report 22889306 ↗
• InjuryAug 8, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS REPORTED AND THROUGH INVESTIGATION THAT A PATIENT WITH A 25MM 2700TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS AND 1 MONTH, DUE TO REGURGITATION. THE PATIENT PRESENTED WITH ACUTE ON CHRONIC HEART FAILURE, SHORTNESS OF BREATH. THE PROCEDURE WAS PERFORMED SUCCESSFULLY WITH A 26MM 9755RSL TRANSCATHETER VALVE.

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

  MAUDE report 22756752 ↗
• InjuryJul 28, 2025Calcified; Insufficient Device Problem Information; Device Stenosis; Calcified; Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY THAT A 25MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 19 DAYS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A VALVE. THE PATIENT WAS REPORTED TO BE STABLE POST-PROCEDURE AND WAS DISCHARGED ON POD # 6. 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 22638424 ↗
• InjuryJun 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 25MM 2700TFX AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AND REPLACED WITH A 23MM 11500A RESILIA AORTIC VALVE AFTER AN IMPLANT DURATION OF 8 YEARS, 3 MONTHS. REASON FOR REINTERVENTION WAS NOT PROVIDED. 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 22357880 ↗
• InjuryJun 24, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 2700TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 11 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. THE TAVR WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS STABLE AND DISCHARGED ON POD #1.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22320740 ↗
• InjuryJun 10, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED A PATIENT WITH A 25MM 2700TFX IMPLANTED FIVE (5) YEARS, 10 MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO AORTIC REGURGITATION. PATIENT PRESENTED WITH HEART FAILURE, SHORTNESS OF BREATH, AND CHEST PAIN. TAVR WAS SUCCESSFULLY PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. PATIENT WAS STABLE AT THE END OF THE PROCEDURE.

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

  MAUDE report 22177740 ↗
• InjuryJun 4, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 2700TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 11 MONTHS DUE TO REGURGITATION. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE TAVR WAS SUCCESSFULLY PERFORMED WITH A 23MM 9755RSL VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE AND DISCHARGED ON POD #1.

  Patient problems: Dyspnea

  MAUDE report 22142750 ↗
• InjuryMay 2, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 2700TFX PERICARDIAL AORTIC VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, TWO (2) MONTHS DUE TO AORTIC STENOSIS AND REGURGITATION. THE PATIENT PRESENTED WITH HEART FAILURE AND STAGE 3 CHRONIC KIDNEY DISEASE. THE TAVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 21952356 ↗
• InjuryApr 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 2700TFX AORTIC VALVE HAS BEEN PLACED UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 11 MONTHS DUE TO LEAFLET THROMBOSIS AND CLOT ON CTA. THE PATIENT PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. THE TAVR PROCEDURE HAS NOT YET BEEN PERFORMED. PATIENT IS BEING TREATED WITH ANTICOAGULATION FOR 3 MONTHS.

  Patient problems: Insufficient Information

  MAUDE report 21900480 ↗
• InjuryMar 28, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A 25MM 2700TFX AORTIC VALVE IN AORTIC POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 2 MONTHS DUE TO AORTIC STENOSIS AND AORTIC REGURGITATION. THE PATIENT PRESENTED WITH HYPOXIA. TAVR WAS COMPLETED WITH A 26MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Hypoxia

  MAUDE report 21720705 ↗
• InjuryMar 22, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS THAT A PATIENT WITH A 25MM 2700TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 6 MONTHS DUE TO SEVERE STENOSIS. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE, DOE AND FATIGUE. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. PER MEDICAL RECORDS, PATIENTS PRESENTED WITH SYMPTOMS OF HEART FAILURE. TTE DEMONSTRATES EF OF 59% AND SEVERE AORTIC VALVE STENOSIS WITH A MEAN GRADIENT OF 42MMHG. THE PATIENT UNDERWENT TRANSCATHETER AORTIC VALVE REPLACEMENT WITH 26MM 9755RSL S3U RESILIA WAS DEPLOYED SUCCESSFULLY WITHOUT ANY COMPLICATIONS. THIS IS A 62-YEAR-OLD MALE PATIENT.

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

  MAUDE report 21671169 ↗
• InjuryFeb 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 2700TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 6 MONTHS DUE TO UNKNOWN REASONS. THE PROCEDURE WAS PERFORMED WITH A 26MM 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 21367676 ↗
• InjuryJan 30, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 2700TFX AORTIC VALVE IN AORTIC POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS AND 2 DAYS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE TAVR WAS SUCCESSFULLY PERFORMED WITH A 26MM 9755RSL VALVE. PATIENT LEFT THE OR STABLE AND WAS TAKEN TO RECOVERY.

  Patient problems: Dyspnea

  MAUDE report 21277656 ↗
• InjuryJan 14, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 2700TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, EIGHT (8) MONTHS DUE TO SEVERE REGURGITATION. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE NYHA CLASS II. THE PROCEDURE WAS PERFORMED WITH A 26MM 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: Heart Failure/Congestive Heart Failure

  MAUDE report 21149805 ↗
• InjuryJan 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 2700TFX AORTIC VALVE, WAS EXPLANTED AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, TWO (2) 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 21094035 ↗
• InjuryDec 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 2700TFX AORTIC VALVE, WAS EXPLANTED AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, NINE (9) MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 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 20894926 ↗
• InjuryDec 3, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 2700TFX 25MM AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 6 MONTHS DUE TO SEVERE STENOSIS. THE PATIENT PRESENTED WITH CARDIOGENIC/SEPTIC SHOCK AND NYHA IV. A 26MM ULTRA WAS IMPLANTED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 20834809 ↗
• InjuryDec 1, 2024Device Stenosis; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 25MM 2700TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SIX (6) YEARS, THREE (3) MONTHS DUE TO STENOSIS. PATIENT PRESENTED WITH SHORTNESS OF BREATH AND LEG SWELLING. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. PATIENT WAS STABLE POST PROCEDURE. THIS IS A 72-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: Dyspnea; Swelling/ Edema

  MAUDE report 20815792 ↗
• InjuryNov 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 25MM 2700TFX AORTIC VALVE IN AORTIC POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 10 MONTHS DUE TO AORTIC INSUFFICIENCY. TAVR WAS COMPLETED WITH A 26MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 20762120 ↗