CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIALBIOPROSTHESIS - MITRAL 6900PTFX (REF 6900PTFX33)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00690103163629), received between May 17, 2021 and Jun 24, 2025 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Gradient Increase” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED AND THROUGH MEDICAL RECORDS, A PATIENT WITH A 33MM 6900PTFX MITRAL VALVE IMPLANTED IN THE TRICUSPID POSITION FOR THREE (3) YEARS, SEVEN (7) MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO SEVERE TRICUSPID REGURGITATION AND STENOSIS. PATIENT PRESENTED WITH ACUTE ON CHRONIC DIASTOLIC HEART FAILURE. TTVR WAS SUCCESSFULLY PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE WITH GOOD RESULT AND NO COMPLICATIONS. PATIENT LEFT ROOM IN STABLE CONDITION.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22321234 ↗
• InjuryMay 30, 2025Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 33MM 6900PTFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 YEARS, 7 MONTHS DUE TO LEAFLETS WITH CALCIFICATION WITH STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE EXPLANTED VALVE WAS REPLACED WITH A 33MM 6900PTFX VALVE. THE PATIENT WAS IN RECOVERY POST PROCEDURE. PATIENT WAS DISCHARGE ON POD#10. CONCOMITANTLY THE PATIENT UNDERWENT A TRICUSPID ANNULOPLASTY REPAIR(34MM 4900). PER PATHOLOGY REPORT, EXPLANTED PROTHESIS WITH FIBROUS TISSUE WITH CALCIFICATIONS, CUSPS REVEALS FIRM, YELLOW-TAN NODULAR AREAS OF POSSIBLE CALCIFICATION. THE PRESENCE OF THESE CALCIFICATIONS MAKE THE VALVE SLIGHTLY STENOTIC.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 22117821 ↗
• InjuryDec 4, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED A PATIENT WITH A 33 MM 6900 PTFX MITRAL VALVE IMPLANTED NINE (9) YEARS, THREE (3) MONTHS, UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO MITRAL STENOSIS. PATIENT PRESENTED WITH HEART FAILURE. TMVR WAS SUCCESSFULLY PERFORMED WITH A 29 MM 9755 RSL TRANSCATHETER VALVE. PATIENT WAS STABLE AT THE END OF THE PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 20844788 ↗
• InjuryNov 17, 2024Insufficient Device Problem Information; Thickening of Material; Insufficient Device Problem Information; Thickening of Material

  IT WAS REPORTED THAT A PATIENT WITH A 33MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS AND SEVEN (7) MONTHS DUE TO UNKNOWN REASON. THE TMVR WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE.

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

  MAUDE report 20702640 ↗
• InjuryApr 11, 2024Fluid/Blood Leak; Mechanical Jam; Fluid/Blood Leak; Mechanical Jam

  PATIENT CALLED VIA THE PATIENT SUPPORT CENTER, THAT HIS 33MM 6900PTFX MITRAL VALVE IMPLANTED FOUR (4) YEARS WAS EXPLANTED AND REPLACED WITH A NON-EDWARDS MECHANICAL VALVE DUE TO A LEAK. THE PATIENT REPORTS 1.5 YEARS AFTER INITIAL MVR SURGERY HE SAW A HEMATOLOGIST FOR NEW ONSET WEAKNESS AND WAS TREATED FOR ANEMIA. ECHO IN (B)(6) 2023 REVEALED THE VALVE LEAK. 11 MONTHS LATER HE UNDERWENT REDO AVR WITH A NON-EDWARDS MECHANICAL VALVE. THE PATIENT REQUESTED A CALL FROM OUR PHYSICIANS TO FURTHER DISCUSS HIS CONCERNS, AND EDWARDS SURGEON SPOKE WITH THE PATIENT. PER MEDICAL RECORDS, PATIENT WAS ON BABY ASPIRIN DAILY. TEE (B)(6) 2022, SHOWED MILD TRANSVALVULAR REGURGITATION, LIKELY SEVERE MITRAL STENOSIS WITH ELEVATED MEAN GRADIENT 12MMHG, LEAFLETS APPEAR TO BE THICKENED AND POSSIBLE THROMBUS ON LEAFLET WITH RESTRICTED MOBILITY. NO OTHER RECORDS PROVIDED AFTER TEE. PATIENT HAD SURGERY 1 YEAR LATER FOR REDO MVR. THIS IS A 53-YEAR-OLD MALE WITH A HISTORY OF MR S/P MVR, CABG X3, LAA LIGATION (2019), CHF IV, ISCHEMIC CARDIOMYOPATHY, STEROID INDUCED HYPERGLYCEMIA, DM II, ATHEROSCLEROTIC HEART DISEASE, CORONARY ARTERY DISEASE, HYPERLIPIDEMIA, IMMUNE THROMBOCYTOPENIA, AUTOIMMUNE HEMOLYTIC ANEMIA,

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

  MAUDE report 19090712 ↗
• InjuryMar 29, 2024Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 33MM 6900PTFX MITRAL VALVE HAS BEEN PLACED UNDER EVALUATION/CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 11 MONTHS DUE TO UNKNOWN REASON.

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

  MAUDE report 19006222 ↗
• InjuryDec 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 33MM 6900PTFX MITRAL VALVE IN MITRAL POSITION WAS EXPLANTED AFTER FOUR (4) YEARS, FOUR (4) MONTHS DUE TO UNKNOWN REASON. THE REPLACEMENT VALVE IS A 33MM 11400M MITRIS RESILIA 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 18395444 ↗
• InjurySep 11, 2023Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  IT WAS REPORTED AND LEARNED THROUGH MEDICAL RECORDS THAT A 33MM 6900PTFX MITRAL VALVE WAS DISABLED AFTER AN IMPLANT DURATION OF FOUR YEARS, NINE MONTHS DUE TO PROSTHETIC MITRAL VALVE STENOSIS. THE PATIENT WAS SYMPTOMATIC. THE TMVR WAS COMPLETED WITH A 29MM 9600TFX TRANSCATHETER VALVE. THE PATIENT DID VERY WELL POST-SURGERY AND WAS DISCHARGED HOME IN STABLE CONDITION ON POD# 4.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 17719724 ↗
• InjuryAug 7, 2023Gradient Increase; Gradient Increase

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 33MM 6900PTFX MITRAL VALVE, IMPLANTED IN THE TRICUSPID POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 4 MONTHS DUE TO SEVERE TRICUSPID STENOSIS. THE PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL VALVE. THE PATIENT WAS TRANSFERRED TO THE CVPR FOR 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 17472399 ↗
• InjuryJun 21, 2023Gradient Increase; Difficult to Open or Close; Insufficient Device Problem Information; Gradient Increase; Difficult to Open or Close; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 33MM 6900PTFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 10 MONTHS DUE TO LEAFLET IMMOBILITY CAUSING SEVERE STENOSIS. THE TMVR WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH HEART FAILURE, DIZZINESS, PULMONARY HYPERTENSION, FATIGUE. THE PATIENT HAD CARDIAC WORKUP OVER TIME SHOWING A WELL SEATED MITRAL VALVE WITH INCREASING GRADIENTS, IMMOBILE LEAFLETS, STENOSIS, AND NO MR.

  Patient problems: Dizziness; Fatigue; Heart Failure/Congestive Heart Failure; Pulmonary Hypertension

  MAUDE report 17175929 ↗
• InjuryJun 14, 2023Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 33MM 6900PTFX PERICARDIAL VALVE IN THE TRICUSPID POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN APPROXIMATE IMPLANT DURATION OF FOUR (4) YEARS, NINE (9) MONTHS DUE TO TRICUSPID STENOSIS. THE PATIENT INITIALLY PRESENTED WITH HEART FAILURE AND RIGHT VENTRICLE DYSFUNCTION. THE TTVR PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS NOTED TO BE STABLE POST PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 17127376 ↗
• InjuryOct 11, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PATIENT WITH A 6900PTFX 33MM MITRAL VALVE, IMPLANTED FOR SEVEN (7) YEARS AND NINE (9) MONTHS, IS BEING EVALUATED FOR A VALVE-IN-VALVE PROCEDURE DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 15580829 ↗
• InjuryMay 27, 2022Fluid/Blood Leak; Gradient Increase; Fluid/Blood Leak; Gradient Increase

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT THIS PATIENT WITH A 6900PTFX 33MM MITRAL VALVE, IMPLANTED FOR SIX (6) YEARS AND 10 MONTHS, UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO STENOSIS AND REGURGITATION. THE TMVR WAS PERFORMED WITH A 9600TFX 29MM. THE PATIENT TAKEN C PACU POSTOPERATIVELY IN STABLE CONDITION. PATIENT WAS DISCHARGE ON POD#11. 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 14525040 ↗
• MalfunctionMay 7, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  EDWARDS RECEIVED NOTIFICATION THAT THE LID OF THIS VALVE MODEL 6900PTFX33 WAS OBSERVED TO BE NOT FULLY CLOSED AND THE SEAL WAS DAMAGED. AS REPORTED, THE NURSE SAW THAT THE RED LABEL WAS TO THE HALF OPENED AND THE LID WASN'T CLOSED AS TIGHTLY AS USUAL. THE ISSUE WAS OBSERVED PRIOR TO USE, WHEN THE NURSE WANTED TO OPEN THE VALVE. REPORTEDLY, THE STERILE BARRIER OF THE VALVE WAS BROKEN SINCE THE RED LABEL WAS DAMAGED. THE VALVE DID NOT GET IN CONTACT WITH THE PATIENT. THE OUTERMOST SHIPPER BOX WAS REPORTED AS TO BE OKAY, AND THE PRIMARY PACKAGING OF THE VALVE WAS NOT PREVIOUSLY OPENED OR DAMAGED. THE DEVICE WAS NOTED AS TO BE AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14317833 ↗
• InjuryMar 20, 2022Degraded; Fluid/Blood Leak; Gradient Increase; Degraded; Fluid/Blood Leak; Gradient Increase

  EDWARDS RECEIVED INFORMATION A PATIENT WITH A 27MM 6900PTFX MITRAL VALVE IMPLANTED FIVE (5) YEARS, 11 MONTHS, UNDERWENT ATTEMPTED VALVE-IN-VALVE PROCEDURE DUE TO STENOSIS. TWO 26MM 9750TFX TRANSCATHETER VALVES WERE ATTEMPTED TO BE IMPLANTED INSIDE THE 27MM SURGICAL VALVE WITHOUT SUCCESS. CASE WAS ABORTED. RE-DO MITRAL VALVE REPLACEMENT IS BEING CONSIDERED AT A LATER DATE.

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

  MAUDE report 13830724 ↗
• InjuryDec 14, 2021Degraded; Gradient Increase; Degraded; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 33MM 6900PTFX MITRAL VALVE IMPLANTED FOR 5 YEARS, 7 MONTHS, UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO DEGENERATION OF MITRAL VALVE BIOPROSTHESIS AND SEVERE MS. THE PATIENT PRESENTED WITH SOB, CHRONIC DIASTOLIC CHF, NYHA CLASS III. THE TMVR WAS SUCCESSFULLY PERFORMED WITH A 29MM 9600TFX TRANSCATHETER VALVE. THE PATIENT TOLERATED PROCEDURE WELL AND WAS TRANSFERRED TO CARDIAC ICU IN STABLE CONDITION FOR FURTHER MANAGEMENT.

  Patient problems: Heart Failure/Congestive Heart Failure; Stenosis

  MAUDE report 12992261 ↗
• InjuryMay 17, 2021Fluid/Blood Leak; Gradient Increase; Fluid/Blood Leak; Gradient Increase

  EDWARDS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 33MM 6900PTFX VALVE, IMPLANTED IN TRICUSPID POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, SIX (6) MONTHS DUE TO STENOSIS. THE TTVR WAS PERFORMED WITH A 29MM 9600TFX 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 11835975 ↗