CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIALBIOPROSTHESIS - MITRAL 6900PTFX (REF 6900PTFX27)Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00690103163599), received between Feb 5, 2021 and Mar 10, 2026 — classified as 59 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (23 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 59 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2026Calcified

  IT WAS LEARNED THROUGH MEDICAL RECORDS THAT A 27MM 6900PTFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 8 MONTHS DUE TO CALCIFICATION, SEVERE STENOSIS, MODERATE REGURGITATION. THE EXPLANTED DEVICE WAS REPLACED WITH A 31MM NON-EDWARDS' VALVE. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH HEART FAILURE AND CARDIOGENIC SHOCK AND UNDERWENT REDO MVR AND REDO AVR WITH AORTIC ROOT REPLACEMENT. INTRAOPERATIVE INSPECTION OF THE MITRAL 6900TFX VALVE REVEALED SOME CALCIUM AND STUCK LEAFLETS, THE VALVE AND PREVIOUSLY PRESERVED CHORDAE WERE RESECTED. A NON-EDWARDS MOSAIC VALVE WAS IMPLANTED IN THE MITRAL POSITION. THE 23MM 3000TFX WAS EXCISED, GIVEN BSA, AGE, AND SIZE OF THE VALVE, KONNO-RASTAN REPAIR WAS NECESSARY. LARGE ANTERIOR AORTOVENTRICULOTOMY WAS FASHIONED UNDER THE PV AND SEPTAL MYOMECTOMY PERFORMED. ONCE THE NEO-LVOT WAS ESTABLISHED A 23MM AVC WAS IMPLANTED. POST BYPASS TEE SHOWED AORTIC GRADIENT 11MMHG AND PRESERVED BIVENTRICULAR FUNCTION. THE PATIENT WAS TRANSPORTED TO THE (B)(6).

  Patient problems: Cardiogenic Shock

  MAUDE report 24564349 ↗
• InjurySep 3, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 2 MONTHS DUE TO MITRAL STENOSIS. THE PATIENT PRESENTED WITH WORSENING SHORTNESS OF BREATH AND FATIGUE. THE TMVR WAS SUCCESSFULLY PERFORMED WITH A 26MM 9750TFX VALVE WITHOUT PATIENT COMPLICATION.

  Patient problems: Dyspnea

  MAUDE report 22955816 ↗
• InjuryAug 19, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 10 MONTHS DUE TO REGURGITATION. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND DYSPNEA ON EXERTION. THE TMVR WAS SUCCESSFULLY PERFORMED WITH A 29MM 9755RSL VALVE. THE PATIENT WAS DISCHARGED POST-PROCEDURE.

  Patient problems: Dyspnea

  MAUDE report 22846404 ↗
• InjuryJul 16, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 11 MONTHS DUE TO SEVERE STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE AND SOB. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 22522122 ↗
• InjuryJul 10, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A 6900PTFX 27MM MITRAL VALVE WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 11 MONTHS DUE TO SEVERE STENOSIS. A 9600TFX 29MM TRANSCATHETER VALVE WAS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 22469578 ↗
• InjuryJul 7, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS AND TEN (10) MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH DYSPNEA. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. THE PATIENT EXPIRED DUE TO TAMPONADE AND CARDIAC PERFORATION.

  Patient problems: Dyspnea

  MAUDE report 22423344 ↗
• InjuryJul 7, 2025Device Stenosis; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 27MM 6900PTFX MITRAL VALVE UNDERWENT REDO MVR AFTER AN IMPLANT DURATION OF 9 YEARS, 6 MONTHS DUE TO STENOSIS. PATIENT PRESENTED WITH HEART FAILURE. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11400M MITRIS RESILIA VALVE. PATIENT WAS STABLE AND WAS DISCHARGED ON POD#13. THIS IS A 72-YEAR-OLD FEMALE 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

  MAUDE report 22410667 ↗
• InjuryJul 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 6900PTFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 9 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 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 22401374 ↗
• InjuryJun 21, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A 27MM 6900PTFX MITRAL VALVE IN MITRAL POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 9 MONTHS DUE TO STENOSIS. TMVR WAS COMPLETED WITH A 26MM 9755RSL TRANSCATHETER VALVE WITH GREAT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22303934 ↗
• InjuryJun 11, 2025Calcified; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Calcified; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 27MM 6900PTFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 2 MONTHS DUE TO CUTIBACTERIUM MODESTUM ENDOCARDITIS. THE EXPLANTED DEVICE WAS REPLACED WITH A 27MM 11400M MITRIS RESILIA MITRAL VALVE. PER PATHOLOGY REPORT, THE EXPLANTED DEVICE TESTED POSITIVE FOR GRAM-POSITIVE COCCI AND CUTIBACTERIUM MODESTUMI. THERE IS ALSO BACKGROUND OF FIBROSIS AND LEAFLETS WERE IRREGULAR, NODULAR, WITH FOCAL CALCIFICATION CONSISTENT WITH MITRAL REGURGITATION.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 22188814 ↗
• InjuryMay 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 27MM 6900PTFX VALVE, IMPLANTED IN TRICUSPID POSITION, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS AND 11 MONTHS DUE TO UNKNOWN REASON. 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 22098297 ↗
• InjuryMay 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS AND EIGHT (8) MONTHS DUE TO UNKNOWN REASON. THE PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22048945 ↗
• InjuryMay 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 2 MONTHS DUE TO UNKNOWN REASONS. THE PROCEDURE WAS PERFORMED WITH A 29MM 9600TFX 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 21955957 ↗
• InjuryApr 28, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A 27MM 6900PTFX MITRAL VALVE IN MITRAL POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 1 MONTH DUE TO STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. TMVR WAS COMPLETED WITH A 26MM 9755RSL TRANSCATHETER VALVE AND PATIENT WAS IN STABLE CONDITION POST-OPERATIVE.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 21918071 ↗
• InjuryApr 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 27MM 6900PTFX MITRAL VALVE IN MITRAL POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 2 MONTHS DUE TO UNKNOWN REASONS. TMVR WAS COMPLETED WITH A 26MM 9755RSL TRANSCATHETER VALVE AND PATIENT WAS IN 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 21872875 ↗
• InjuryMar 28, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 27MM MITRAL VALVE HAS BEEN PLACED UNDER EVALUATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN UNKNOWN IMPLANT DURATION DUE TO STENOSIS.

  Patient problems: Insufficient Information

  MAUDE report 21725178 ↗
• InjuryMar 7, 2025Fluid/Blood Leak; Intravalvular regurgitation; Fluid/Blood Leak; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 6900PTFX PERICARDIAL MITRAL VALVE WAS PLACED UNDER EVALUATION FOR VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF ONE (1) YEAR, 11 MONTHS DUE TO MITRAL REGURGITATION. THE PATIENT INITIALLY PRESENTED WITH CHF.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 21554391 ↗
• InjuryJan 30, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS DUE TO SEVERE STENOSIS. THE TMVR WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 21276657 ↗
• InjuryNov 21, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 27 MM 6900 PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF OVER 8 YEARS DUE TO STENOSIS. THE PROCEDURE WAS PERFORMED WITH A 29 MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 20748152 ↗
• InjuryNov 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 27MM 6900PTFX PERICARDIAL MITRAL VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, FOUR (4) MONTHS DUE TO UNKNOWN REASONS. THE TMVR 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 20707450 ↗
• InjuryAug 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A 27MM 6900PTFX VALVE IN THE MITRAL POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AND IMPLANT DURATION OF 8 YEARS, 5 MONTHS DUE TO THROMBUS AND/OR PANNUS CAUSING MODERATE STENOSIS. THE TMVR WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. PER MEDICAL RECORDS, TEE ON (B)(6) 2023 NOTED TO HAVE LEAFLET THROMBOSIS AND WAS STARTED ON COUMADIN. THEN, TEE ((B)(6)2024) SHOWED MODERATE-SEVERE BIOPROSTHETIC VALVE STENOSIS SECONDARY TO THROMBUS/PANNUS FORMATION. THE PATIENT PRESENTED WITH ACUTE DIASTOLIC HEART FAILURE AND CARDIOGENIC SHOCK. THE PATIENT IS A 59 Y.O. FEMALE WITH HISTORY OF MVR(2016), SEVERE TR, HEART FAILURE, BIVENTRICULAR FAILURE, NICM AND HFREF (EF 40%), COPD, CKD STAGE 3, HTN, HLD, NSVT S/P ICD AND AF ON WARFARIN, CHRONIC THROMBOCYTOPENIA

  Patient problems: Heart Failure/Congestive Heart Failure; Thrombosis/Thrombus

  MAUDE report 20071178 ↗
• InjuryJul 11, 2024Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 2 MONTHS DUE TO UNKNOWN REASONS. THE PROCEDURE WAS PERFORMED WITH A 26MM 9750TFX 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: Chest Pain; Dyspnea; Fatigue; Insufficient Information; Swelling/ Edema

  MAUDE report 19726912 ↗
• InjuryJun 28, 2024Device Stenosis; Device Stenosis

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 27MM 6900PTFX PERICARDIAL MITRAL VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, 10 MONTHS DUE TO MITRAL STENOSIS. THE PATIENT INITIALLY PRESENTED WITH SHORTNESS OF BREATH. THE TMVR PROCEDURE WAS PERFORMED WITH A 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS STABLE POST PROCEDURE AND THEN DISCHARGED ON POD #1.

  Patient problems: Dyspnea

  MAUDE report 19634914 ↗
• InjuryJun 27, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 6900PTFX VALVE IN THE AORTIC POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS AND TEN (10) MONTHS DUE TO STENOSIS. A TAVR PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. THE PATIENT PRESENTED TO THE HOSPITAL FOR DYSPNEA. THE PATIENT WAS STABLE POST-PROCEDURE AND DISCHARGED ON POD# 1.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 19630078 ↗
• InjuryJun 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT WITH A 27MM 6900PTFX MITRAL VALVE, HAS BEEN PLACED UNDER EVALUATION FOR A RE-INTERVENTION AFTER IMPLANT DURATION OF SEVEN (7) YEARS, FOUR (4) MONTHS DUE TO UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 19510402 ↗