CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIALBIOPROSTHESIS - MITRAL 6900PTFX (REF 6900PTFX29)Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00690103163605), received between Apr 16, 2021 and Nov 10, 2025 — classified as 31 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 31 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 11 YEARS, 7 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE. THE PROCEDURE WAS INITIALLY PERFORMED WITH A 29MM 9600TFX TRANSCATHETER VALVE HOWEVER, THE SURGERY WAS ABORTED AND THE TRANSCATHETER VALVE WAS NOT IMPLANTED IN THE PATIENT. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE AND BEING EVALUATED FOR SEPTAL ALCOHOL ABLATION. PER REPORTER, THE PROCEDURE WAS INITIALLY PERFORMED WITH A 29MM 9600TFX TRANSCATHETER VALVE. THE SURGICAL TEAM ATTEMPTED TO PERFORM A LAMPOON PROCEDURE; HOWEVER, IT WAS DETERMINED THAT THE ANTERIOR MITRAL LEAFLET (AML) WAS NOT SUCCESSFULLY LACERATED. THE TEAM DECIDED TO ABORT THE SURGERY AFTER 4.5 HOURS AND EVALUATE THE PATIENT FOR SEPTAL ALCOHOL ABLATION. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23512057 ↗
• InjuryOct 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 29MM 6900PTFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF EIGHT (8) YEAR, AND 26 DAYS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 31MM 11400A MITRAL 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 23274943 ↗
• InjuryJul 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 10 MONTHS DUE TO UNKNOWN REASONS. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22491087 ↗
• InjuryJun 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 29MM 6900PTFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 2 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED DEVICE WAS REPLACED WITH A 31MM 11400M MITRAL 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 22206349 ↗
• InjuryMay 12, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH AN 29MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION EIGHT (8) YEARS AND 11 MONTHS DUE TO STENOSIS. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22006575 ↗
• InjuryMar 31, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 29MM 6900PTFX MITRAL 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 29MM 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 21729057 ↗
• InjuryFeb 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 29MM 6900PTFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 3 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11400M 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 21379639 ↗
• InjuryJan 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 29MM 6900PTFX PERICARDIAL MITRAL VALVE UNDERWENT REDO MITRAL VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, 11 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 11400M MITRIS 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 21289346 ↗
• InjuryDec 9, 2024Insufficient Device Problem Information; Thickening of Material; Insufficient Device Problem Information; Thickening of Material

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 29MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 6 MONTHS DUE TO MILD LEAFLET THICKENING/RESTRICTED MOTION WITH STENOSIS AND REGURGITATION. THE PATIENT PRESENTED WITH HEART FAILURE. THE PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE WITH NO APPARENT COMPLICATIONS. THE PATIENT WAS TRANSFERRED TO ICU.

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

  MAUDE report 20886736 ↗
• InjurySep 19, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED A PATIENT WITH A 29MM 6900PTFX MITRAL VALVE IMPLANTED FIVE (5) YEARS, SIX (6) MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO STENOSIS. PATIENT PRESENTED WITH CONGESTIVE HEART FAILURE AND SHORTNESS OF BREATH. TMVR WAS SUCCESSFULLY PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 20256893 ↗
• InjurySep 10, 2024Degraded; Degraded

  IT WAS LEARNT THROUGH "LONG-TERM RETROSPECTIVE CLINICAL FOLLOW-UP STUDY OF PERIMOUNT BOVINE PERICARDIAL BIOPROSTHETIC VALVE" THAT THIS PATIENT WITH A 6900PTFX29 VALVE IMPLANTED IN MITRAL POSITION UNDERWENT RE-OPERATION FOR VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS AND FIVE (5) MONTHS DUE TO VALVE DEGENERATION LEADING TO MITRAL STENOSIS AND REGURGITATION. AS REPORTED, THE PATIENT WAS HOSPITALIZED FOR HEART FAILURE-RELATED SYMPTOMS FOUR MONTHS BEFORE VALVE RE-OPERATION AND ULTRASOUND SHOWED MITRAL STENOSIS WITH REGURGITATION. AFTER ADMISSION, SHE WAS GIVEN ANTICOAGULATION, DIURETICS, AND VASODILATOR TREATMENT AND WAS DISCHARGED. THE PATIENT WAS ADMITTED AGAIN AT HOSPITAL AFTER FOUR MONTHS FOR VALVE REOPERATION. A NON EDWARDS DEVICE WAS USED IN REPLACEMENT. THE PATIENT WAS DISCHARGED AND WAS NOTED AS TO BE RECOVERED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 20178990 ↗
• InjuryAug 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY THAT A MODEL 6900PTFX 29MM PERICARDIAL MITRAL VALVE WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 9 MONTHS DUE TO UNKNOWN REASONS. A 9755RSL 29MM TRANSCATHETER VALVE WAS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 20006559 ↗
• InjuryJul 1, 2024Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 6900PTFX MITRAL VALVE HAS BEEN PLACED UNDER EVALUATION/CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 4 MONTHS DUE TO UNKNOWN REASON.

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

  MAUDE report 19650201 ↗
• InjuryJun 28, 2024Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 6900PTFX 29MM VALVE, IMPLANTED IN MITRAL POSITION, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 YEARS AND 11 MONTHS DUE TO UNKNOWN REASONS. THE VALVE WAS REPLACED WITH A 11400M 29MM VALVE.

  Patient problems: Insufficient Information; Pulmonary Hypertension

  MAUDE report 19638017 ↗
• InjuryMar 29, 2024Degraded; Degraded

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 29MM 6900PTFX VALVE, IMPLANTED IN MITRAL POSITION, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS AND 10 MONTHS DUE TO CALCIFICATION, DEGENERATION, LEAFLET MOVEMENT RESTRICTION, AND STENOSIS. THE PATIENT WAS PRESENTED WITH WORSENING DYSPNEA AND EDEMA. THE VALVE WAS REPLACED WITH A 11400M 31MM VALVE. THE PATIENT WAS DISCHARGED ON POD#3. THE PATIENT IS A 68-YEAR-OLD FEMALE WITH HISTORY OF MVR (2019), RHEUMATIC HEART DISEASE, CAD, CARDIOMEGALY, CHF, LAA CLIPPING, MAZE (2019), AFIB/AFLUTTER S/P ABLATION (2023), HTN, HLD, OSA, AND ANEMIA.

  Patient problems: Dyspnea; Swelling/ Edema

  MAUDE report 19005594 ↗
• InjuryFeb 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A PATIENT WITH A 29MM 6900PTFX MITRAL VALVE IMPLANTED FOUR (4) YEARS, FOUR (4) MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO UNKNOWN REASONS. TMVR WAS SUCCESSFULLY PERFORMED WITH A 29MM SAPIEN 3 TRANSCATHETER VALVE WITH GOOD RESULT.

  Patient problems: Insufficient Information

  MAUDE report 18699882 ↗
• InjuryOct 24, 2023Calcified; Gradient Increase; Patient Device Interaction Problem; Calcified; Gradient Increase; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION THAT A 6900PTFX 29MM MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS, 4 MONTHS DUE TO SEVERE STENOSIS. THE PATIENT PRESENTED WITH CHF AND SOB. PER PRODUCT EVALUATION VEGETATION, CALCIFICATION, AND PANNUS WERE CONFIRMED.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 17998544 ↗
• InjuryAug 29, 2023Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A 29MM MITRAL VALVE WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 11 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH NYHA CLASS III. A 29MM TRANSCATHETER VALVE WAS IMPLANTED WITH LAMPOON PROCEDURE. THE PROCEDURE WENT WELL.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 17642493 ↗
• InjuryJun 21, 2023Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SIX YEARS, TEN MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. A 29MM 9755RSL VALVE WAS SUCCESSFULLY IMPLANTED AND PATIENT WAS STABLE AT THE END OF THE PROCEDURE.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 17175473 ↗
• InjuryFeb 2, 2023Degraded; Degraded

  IT WAS LEARNED VIA THE IMPLANT PATIENT REGISTRY THAT A 6900PTFX 29MM BIOPROSTHETIC MITRAL VALVE, IMPLANTED FOR SIX (6) YEARS AND TWO (2) MONTHS, WAS EXPLANTED DUE TO TORN LEAFLETS. THE EXPLANTED DEVICE WAS REPLACED WITH A 11400M 29MM MITRIS RESILIA VALVE. THE PATIENT UNDERWENT CABG PROCEDURE CONCOMITANTLY. PER PATHOLOGY REPORT, THE PROSTHETIC VALVE HAD THREE THIN FOCALLY TORN APPEARING VALVE CUSPS. THE VALVE CUSPS DISPLAYED FOCAL YELLOW FATTY STREAKS. NO VEGETATIONS IDENTIFIED. 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 16284062 ↗
• InjuryDec 22, 2022Fluid/Blood Leak; Gradient Increase; Perivalvular Leak; Detachment of Device or Device Component; Insufficient Device Problem Information; Fluid/Blood Leak; Gradient Increase; Perivalvular Leak; Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS LEARNED FROM IMPLANT PATIENT REGISTRY THAT A MODEL 6900PTFX 29MM MITRAL VALVE WAS EXPLANTED AND REPLACED WITH A 6900PTFX 31MM VALVE AFTER AN IMPLANT DURATION OF 1 YEAR, 6 MONTHS DUE TO UNKNOWN REASONS. THE PATIENT WAS IN RECOVERY POST OPERATION. 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 16036296 ↗
• InjuryJun 7, 2022Fluid/Blood Leak; Gradient Increase; Perivalvular Leak; Fluid/Blood Leak; Gradient Increase; Perivalvular Leak

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 6900PTFX PERICARDIAL VALVE IN THE TRICUSPID POSITION WAS PLACED UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF FOUR (4) YEARS, 11 MONTHS DUE TO TRICUSPID REGURGITATION.

  Patient problems: Angina; Dyspnea; Insufficient Information

  MAUDE report 14622125 ↗
• InjuryApr 15, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT THIS PATIENT WITH A 6900PTFX 29MM VALVE, IMPLANTED FOR FOUR (4) YEARS AND THREE (3) MONTHS, UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO UNKNOWN REASONS. THE TMVR WAS PERFORMED WITH A 9600TFX 29MM. 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 14119612 ↗
• InjuryJan 28, 2022Fluid/Blood Leak; Gradient Increase; Fluid/Blood Leak; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 6900PTFX PERICARDIAL MITRAL VALVE WAS PLACED UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SIX (6) YEARS, FIVE (5) MONTHS DUE TO MITRAL STENOSIS AND REGURGITATION.

  Patient problems: Insufficient Information

  MAUDE report 13385890 ↗
• InjuryNov 23, 2021Degraded; Fluid/Blood Leak; Gradient Increase; Degraded; Fluid/Blood Leak; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 6900PTFX MITRAL VALVE, IMPLANTED IN THE TRICUSPID POSITION, UNDERWENT A VALVE-IN-VALVE AFTER AN IMPLANT DURATION OF FOUR YEARS, FIVE MONTHS DUE TO SEVERE TRICUSPID STENOSIS, SEVERE REGURGITATION, AND THICKENED LEAFLETS. THE TTVR WAS PERFORMED WITH A 29MM 9600TFX VALVE. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 12862325 ↗