CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIALBIOPROSTHESIS - MITRAL 6900PTFX (REF 6900PTFX25)Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00690103163582), received between Feb 10, 2021 and Jan 6, 2026 — classified as 38 injuries.

The most frequently reported specific device problem is “Gradient Increase” (13 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 38 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2026Perivalvular Leak

  IT WAS LEARNED THROUGH THE INVESTIGATION OF ANOTHER COMPLAINT [(B)(4)] THAT A PATIENT UNDERWENT MITRAL VALVE REPLACEMENT WITH A 25MM 6900PTFX PERICARDIAL MITRAL VALVE THAT WAS COMPLICATED BY CHORDAE TENDINAE RUPTURE AND PVL. URGENT REDO STERNOTOMY WAS PERFORMED AFTER AN UNKNOWN IMPLANT DURATION IN ORDER TO PERFORM THE REPAIR.

  Patient problems: Insufficient Information

  MAUDE report 23977640 ↗
• InjurySep 15, 2025Calcified; Adverse Event Without Identified Device or Use Problem; Calcified; Adverse Event Without Identified Device or Use Problem

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS THAT A PATIENT WITH A 25MM 6900PTFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 YEARS, 9 MONTHS DUE TO CALCIFICATION, VEGETATION, IMMOBILE LEAFLETS, AND SEVERE STENOSIS. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 11400M VALVE. THE PATIENT WAS TAKEN TO THE ICU IN STABLE CONDITION POST PROCEDURE. PER MEDICAL RECORDS, PRE-OP TEE SHOWED VEGETATION ON MITRAL VALVE WITH MODERATE STENOSIS AND POORLY MOBILE LEAFLETS. REDO STERNOTOMY WAS PERFORMED TO EXPLANT THE 25MM PLUS MITRAL VALVE AND REPLACE WITH A 29MM MITRIS. INTRA-OPERATIVELY, THE MITRAL VALVE WAS FOUND TO BE SEVERELY DISEASED BEYOND REPAIR. VALVE WAS REMOVED AND POSTERIOR LEAFLET WAS DEBRIDED TO ACCOMMODATE A LARGER VALVE AND REDUCE OBSTRUCTION. POST-OP TEE REVEALED STABLE RV/LV FUNCTION AND CONFIRMED NEW MITRAL VALVE WAS WELL SEATED WITH MOBILE LEAFLETS. THE PATIENT WAS TAKEN TO THE ICU IN STABLE CONDITION POST PROCEDURE. PER PATHOLOGY REPORT, THE EXPLANTED MITRAL VALVE WAS RECEIVED WITH POSSIBLE CALCIFICATIONS AND TRACE FIBROUS TISSUE ATTACHED TO THE RING OF THE VALVE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A

  Patient problems: Insufficient Information

  MAUDE report 23057559 ↗
• InjuryAug 27, 2025Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 YEARS, 10 MONTHS DUE TO CALCIFICATION AND SEVERE STENOSIS. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE. THE TMVR WAS SUCCESSFULLY PERFORMED WITH A 26MM 9755RSL VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22905312 ↗
• InjuryJul 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 25MM 6900PTFX MITRAL VALVE IN MITRAL POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 4 MONTHS DUE TO UNKNOWN REASON. TMVR WAS COMPLETED WITH A 26MM 9755RSL TRANSCATHETER VALVE AND PATIENT WAS IN RECOVERY POST-OPERATIVE. 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 22554037 ↗
• InjuryJul 14, 2025Device Stenosis; Device Stenosis

  THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE. THE PATIENT WAS TRANSFERRED TO ICU POST-PROCEDURE AND DISCHARGED ON POD# 7.

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

  MAUDE report 22496283 ↗
• InjuryJun 23, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 6900PTFX MITRAL VALVE, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 10 MONTHS DUE TO STENOSIS. THE TMVR WAS SUCCESSFULLY PERFORMED WITH A 26MM 9755RSL VALVE. THE PATIENT LEFT THE OR ROOM IN STABLE CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 22309197 ↗
• InjuryJun 20, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 6900PTFX MITRAL VALVE, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS AND 6 MONTHS DUE TO STENOSIS. THE PATIENT WAS PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. THE VALVE WAS REPLACED WITH A 2MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22302771 ↗
• InjuryJun 7, 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 25MM 6900PTFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 YEARS, 10 MONTHS DUE TO UNKNOWN REASON. THE MITRAL VALVE WAS REPLACED WITH A 25MM 11400M VALVE. THE PATIENT WAS IN RECOVERY POST PROCEDURE. THE PATIENT CONCOMITANTLY UNDERWENT AVR WITH A 19MM 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 22163112 ↗
• InjuryFeb 21, 2025Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, TWO (2) MONTHS DUE TO UNKNOWN REASONS. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 21440334 ↗
• InjuryFeb 10, 2025Device Stenosis; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, NINE (9) MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE. THE PROCEDURE WAS PERFORMED WITH A 23MM 9600TFX TRANSCATHETER VALVE. THE PATIENT WAS TAKEN TO THE ICU POST PROCEDURE. THE PATIENT WAS DISCHARGED ON POD #5. 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 21349424 ↗
• InjuryJan 28, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 6 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE. THE TMVR PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS IN RECOVERY POST PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 21252909 ↗
• InjuryJan 16, 2025Device Stenosis; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS DUE TO STENOSIS AND MILD CENTRAL LEAK. THE 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: Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 21174992 ↗
• InjuryJan 13, 2025Calcified; Device Stenosis; Calcified; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 2 MONTHS DUE TO STENOSIS. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE.

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

  MAUDE report 21144134 ↗
• InjuryJun 6, 2024Calcified; Calcified

  IT WAS REPORTED AND THROUGH INVESTIGATION THAT A PATIENT WITH A 25MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 12 DAYS DUE TO CALCIFICATION WITH REGURGITATION. THE PATIENT PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. THE PROCEDURE WAS PERFORMED WITH A 23 MM 9750TFX TRANSCATHETER VALVE. PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 19477845 ↗
• InjuryJun 1, 2024Device Stenosis; Device Stenosis

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 25MM 6900PTFX PERICARDIAL MITRAL VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, 11 MONTHS DUE TO MITRAL STENOSIS. THE PATIENT INITIALLY PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. THE TMVR PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS STABLE POST PROCEDURE AND DISCHARGED ON POD #6.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 19441743 ↗
• InjuryMay 3, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A 25MM 6900PTFX VALVE IN THE MITRAL POSITION IS UNDER EVALUATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 9 MONTHS DUE TO STENOSIS.

  Patient problems: Insufficient Information

  MAUDE report 19239415 ↗
• InjuryApr 24, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A 25MM 6900PTFX IN THE MITRAL POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, SEVEN (7) MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE, DYSPNEA, AND HYPOXEMIC RESPIRATORY FAILURE. THE TMVR WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. THE PATIENT IS DOING WELL POST PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 19175113 ↗
• InjuryApr 12, 2024Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT PATIENT WITH A 25MM 6900PTFX MITRAL VALVE UNDERWENT VALVE-IN-VALVE PROCEDURE AFTER IMPLANT DURATION OF SIX (6) YEARS, SIX (6) MONTHS DUE TO STENOSIS. THE PROCEDURE WAS PERFORMED WITH 26MM 9750TFX TRANSCATHETER VALVE. THE PROCEDURE WAS UNEVENTFUL AND PATIENT REMAINED THROUGHOUT.

  Patient problems: Insufficient Information

  MAUDE report 19099072 ↗
• InjuryMar 25, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 6900PTFX 25MM MITRAL VALVE UNDERWENT A REDO PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 11 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SOB. A 11400M 31MM WAS IMPLANTED IN REPLACEMENT.

  Patient problems: Dyspnea

  MAUDE report 18974209 ↗
• InjuryOct 25, 2023Calcified; Degraded; Gradient Increase; Difficult to Open or Close; Patient Device Interaction Problem; Calcified; Degraded; Gradient Increase; Difficult to Open or Close; Patient Device Interaction Problem

  IT WAS REPORTED THAT A 25MM 6900PTFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS, ELEVEN MONTHS DUE TO SEVERELY DISEASED FROZEN LEAFLETS AND SEVERE STENOSIS. THE EXPLANTED VALVE WAS REPLACED WITH A NON-EDWARDS MECHANICAL VALVE. PER MEDICAL RECORDS, THE PATIENT PRESENT WITH CONGESTIVE HEART FAILURE CLASS IV AND UNDERWENT REDO AVR MINI STERNOTOMY. INTRAOPERATIVELY THE MITRAL VALVE WAS DENSELY OVERGROWN INTO THE ENDOCARDIUM, IT WAS A LONG TEDIOUS PROCESS TO DISSECT THE VALVE. THE LEAFLETS APPEARED NEAR FROZEN AND THERE WAS SIGNIFICANT CALCIFICATION IN THE P3 SEGMENT OF THE VENTRICULAR SIDE OF THE ANNULUS THAT WAS DEBRIDED. A NON-EDWARDS MECHANICAL VALVE (ON-X) WAS IMPLANTED IN REPLACEMENT. POST TEE SHOWED GOOD VALVE FUNCTION WITH NO PVL. THE PATIENT WAS TRANSFERRED BACK TO THE ICU IN CRITICAL BUT STABLE CONDITION.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 18007765 ↗
• InjurySep 1, 2023Calcified; Difficult to Open or Close; Device Stenosis; Calcified; Difficult to Open or Close; Device Stenosis

  IT WAS REPORTED A PATIENT WITH A 25MM 6900PTFX MITRAL VALVE IMPLANTED ONE (1) YEAR, SEVEN (7) MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO MITRAL STENOSIS. TMVR WAS SUCCESSFULLY PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE. PER PHYSICIAN SURGICAL VALVE FAILED PREMATURELY DUE TO END STAGE RENAL DISEASE.

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

  MAUDE report 17671917 ↗
• InjuryMay 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED THAT A PATIENT WITH A 25MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 10 MONTHS DUE TO UNKNOWN REASON. THE TMVR WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. THE 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 16994209 ↗
• InjuryApr 19, 2023Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 6900PTFX VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 4 MONTHS DUE TO UNKNOWN REASON. 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: Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 16772333 ↗
• InjuryMar 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 6900PTFX MITRAL VALVE IS UNDER EVALUATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 11 MONTHS DUE TO UNKNOWN REASONS. THE TMVR IS PLANNED BUT HAS NOT BEEN SCHEDULED.

  Patient problems: Insufficient Information

  MAUDE report 16632607 ↗
• InjuryFeb 27, 2023Gradient Increase; Gradient Increase

  EDWARDS RECEIVED INFORMATION A PATIENT WITH A 25MM 6900PTFX MITRAL VALVE IMPLANTED TWO (2) YEARS, TWO (2) MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO MITRAL STENOSIS. PATIENT PRESENTED WITH SHORTNESS OF BREATH AND HEART FAILURE. A 26MM 9750TFX TRANSCATHETER VALVE WAS SUCCESSFULLY IMPLANTED INSIDE THE 25MM VALVE.

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

  MAUDE report 16444492 ↗