CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS 7300TFX (REF 7300TFX27)Recalls & reported problems

Summary

The FDA's MAUDE database contains 425 adverse event reports that list this exact device (DI 00690103186260), received between Jan 28, 2021 and Jul 30, 2026 — classified as 1 death, 422 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (177 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 425 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Insufficient Device Problem Information

  It was learned via the patient registry that a patient with a 27mm 7300TFX pericardial mitral valve underwent redo mitral valve replacement after an implant duration of six (6) years, 11 months due to unknown reasons. The explanted valve was replaced with a 27mm 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 50087015 ↗
• InjuryJul 28, 2026Insufficient Device Problem Information

  It was learned through Implant Patient Registry that a patient with a 27mm 7300TFX 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 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 50053277 ↗
• InjuryMay 26, 2026Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 27 MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 1 MONTH DUE TO SEVERE STENOSIS. THE PATIENT PRESENTED WITH ACUTE ON CHRONIC HEART FAILURE. THE TMVR PROCEDURE WAS PERFORMED WITH A 29 MM 9600TFX VALVE. PER MEDICAL RECORDS, POST TMVR PROCEDURE, TEE SHOWED LARGE IATROGENIC ASD WITH PREDOMINANTLY LEFT-RIGHT FLOW. GIVEN RV DILATION AND PHTN, DECISION WAS MADE TO PROCEED WITH ASD CLOSURE WITH A 20 MM AMPLATZER OCCLUDER. THE PATIENT WAS STABLE POST PROCEDURE AND DISCHARGED ON POD #1.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 25285701 ↗
• InjuryApr 13, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 1 MONTH 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 24866208 ↗
• InjuryApr 9, 2026Calcified

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT A 7300TFX 27MM MITRAL VALVE WAS EXPLANTED REPLACED WITH A 11400M 31MM AFTER AN IMPLANT DURATION OF 9 YEARS DUE TO CALCIFICATION AND DEGENERATION. THE PATIENT PRESENTED WITH SOB. 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

  MAUDE report 24834685 ↗
• InjuryApr 7, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 27MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 11 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED DEVICE WAS REPLACED WITH AN UNKNOWN DEVICE. 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 24802749 ↗
• InjuryMar 13, 2026Calcified

  IT WAS REPORTED THAT A 7300TFX 27MM MITRAL VALVE WAS EXPLANTED AND REPLACED WITH A NON-EW VALVE AFTER AN IMPLANT DURATION OF 8 YEARS, 10 MONTHS DUE TO SEVERE STENOSIS AND HEAVY CALCIFICATION. THE PATIENT PRESENTED WITH ACUTE ON CHRONIC HF WITH PRESERVED EF. PER MEDICAL RECORDS, INTRAOPERATIVE INSPECTION OF MV REVEALED HEAVY CALCIFICATION. THE SURGEON RESECTED THE VALVE AND REPLACED IT WITH A NON-EW PORCINE BIOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO ICU IN STABLE CONDITION. THE PATIENT DISCHARGED ON POD#6.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24590932 ↗
• InjuryFeb 26, 2026Patient Device Interaction Problem

  EDWARDS REVIEWED THE LITERATURE ARTICLE, "SIMULTANEOUS TRANSCATHETER TRICUSPID VIV AND MITRAL VIV REPLACEMENT WITH LAMPOON IN A PATIENT WITH EARLY BIOPROSTHETIC MV AND TV DYSFUNCTION FROM HALT", APRIL 1, 2025, BY ANDREW CHIOU, FADY IBRAHIM, CURTISS STINIS. IT WAS LEARNED THAT A PATIENT WITH A UNKNOWN 27MM EDWARDS MAGNA EASE VALVE IN THE MITRAL POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER APPROXIMATELY 2 YEARS DUE TO THROMBOSIS/HALT WITH SEVERE MITRAL REGURGITATION. THE TMVR AND LAMPOON PROCEDURES WAS PERFORMED WITH A 26MM 9755RSL VALVE. PER CLINICAL CASE, THE PATIENT PRESENTED WITH PROGRESSIVE FATIGUE, SHORTNESS OF BREATH, SIGNIFICANT VOLUME OVERLOAD. PRE-OPERATIVE TEE SHOWED AN IMMOBILE, THICKENED LATERAL BIOPROSTHETIC MV LEAFLET LEADING TO SEVERE MR. SHORT, THICKENED, IMMOBILE BIOPROSTHETIC TV LEAFLETS LEADING TO TORRENTIAL TR. CARDIAC CT REVEALED MV AND TV LEAFLET THROMBOSIS WITH EVIDENCE OF HALT AND REDUCED LEAFLET MOBILITY. ANTICOAGULATION THERAPY WAS INITIATED HOWEVER PATIENT CONTINUED TO HAVE PERSISTENT SYMPTOMS AND VALVULAR DYSFUNCTION AND UNDERWENT VIV. POST-PROCEDURE TTE SHOWED WELL SEATED MV AND TV WITH NO RESIDUAL MR OR TR.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24456203 ↗
• InjuryFeb 6, 2026Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 27MM 7300TFX PERICARDIAL MITRAL VALVE UNDERWENT REDO MITRAL VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF TWO (2) YEARS, THREE (3) 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 24281977 ↗
• InjuryFeb 3, 2026Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 9 MONTHS DUE TO REGURGITATION AND SEVERE STENOSIS. PATIENT PRESENTED WITH NYHA CLASS IV HEART FAILURE AND SHORTNESS OF BREATH. THE PROCEDURE WAS PERFORMED WITH A 29MM TRANSCATHETER VALVE. PER MEDICAL RECORDS PATIENT HAD 4 ADMISSIONS FOR MANAGEMENT OF HEART FAILURE EXACERBATION WITH EXTREME DYSPNEA. IT WAS REPORTED THAT THE HEART FAILURE WAS VALVULAR HEART FAILURE. PATIENT PRESENTED FOR TMVR FOR SEVERE STENOSIS AND MODERATE REGURGITATION WITH VALVULAR HEART FAILURE AND FATIGUE. PROCEDURE WAS SUCCESSFUL.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24246385 ↗
• InjuryJan 13, 2026Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 7300TFX MITRAL VALVE IMPLANTED FOUR (4) YEARS, 10 MONTHS, UNDERWENT EMERGENT VALVE-IN-VALVE PROCEDURE DUE TO SEVERE CALCIFIC MITRAL VALVE STENOSIS. TMVR WAS SUCCESSFULLY PERFORMED WITH A 29MM S3UR TRANSCATHETER VALVE. PATIENT ON VENTILATOR AND ECMO.

  Patient problems: Insufficient Information

  MAUDE report 24063121 ↗
• DeathJan 2, 2026Calcified

  IT WAS REPORTED AND LEARNED THROUGH THE INVESTIGATION THAT A PATIENT WITH A 27MM 7300TFX MITRAL VALVE, IMPLANTED FOR 12 YEARS, 7 MONTHS, HAS BEEN PLACED UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE DUE TO CALCIFICATION AND STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. PER THE HOSPITAL, THE PATIENT DID NOT MEET THE CRITERIA FOR TMVR AND WAS PLACED ON COMFORT MEASURES AND DNR. THE PATIENT EXPIRED ON (B)(6) 2025.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23952196 ↗
• InjuryDec 14, 2025Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT AFTER IMPLANT OF A 27MM 7300TFX MITRAL VALVE, THE PATIENT DEVELOPED LARGE PVL AND UNDERWENT PERCUTANEOUS PVL PLUG CLOSURE AFTER IMPLANT DURATION OF 4 YEARS, 4 MONTHS. PER MEDICAL RECORDS, THE PATIENT UNDERWENT TRANSCATHETER CLOSURE OF PVL USING A 10MM AMPLATZER MUSCULAR VENTRICULOSEPTAL DEFECT DEVICE. THE DEVICE WAS SUCCESSFULLY DEPLOYED IN GOOD POSITION. POST TEE SHOWED MARKED IMPROVEMENT IN DEGREE OF PVL. THE PATIENT LEFT THE CATH LAB IN STABLE CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 23799482 ↗
• InjuryDec 8, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SIX (6) YEARS AND FOUR (4) MONTHS DUE TO SEVERE STENOSIS. THE PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL SAPIEN 3 TRANSCATHETER VALVE. DURING THE VALVE-IN-VALVE PROCEDURE, THE FIRST SAPIEN 3 SYSTEM WAS INSERTED, BUT THE OPERATING TEAM WAS UNABLE TO POSITION IN THE MITRAL VALVE. THE DEVICE WAS REMOVED (2025-31744-01) AND A SECOND S3UR SYSTEM WAS INSERTED IN REPLACEMENT. THE PROCEDURE WAS FURTHER COMPLICATED BY PATIENT ANATOMY AND DIFFICULTY POSITIONING OF SECOND DEVICE REQUIRING ANOTHER REMOVAL. THE PATIENT EXPIRED LATER THAT SAME DAY DUE TO COMPARTMENT SYNDROME, WHICH LED TO SIGNIFICANT BLOOD LOSS.

  Patient problems: Insufficient Information

  MAUDE report 23740938 ↗
• InjuryNov 17, 2025Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 27MM 7300TX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 2 MONTHS DUE TO DEGENERATION AND PARAVALVULAR LEAK. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 7300TFX. THE PATIENT WAS REPORTED TO BE IN RECOVERY AND WAS DISCHARGED ON POD #15. A BIOPROSTHETIC MITRAL VALVE WAS RECEIVED PER HOSPITAL PATHOLOGY REPORT. PER GROSS EXAMINATION, OUTER RING ARE FOCALLY COVERED BY SOFT TISSUE AND CALCIFICATIONS. THE 3 CUSPS ARE TAN-YELLOW, FREELY MOVABLE WITHOUT FUSED COMMISSURES, NO VEGETATIONS OR CALCIFICATIONS. PER MICROSCOPIC EXAM/DIAGNOSIS, THE VALVE TISSUE HAS MYXOID DEGENERATION AND FOCAL DYSTROPHIC CALCIFICATION. 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

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 23570261 ↗
• InjuryOct 20, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED AND LEARNED THROUGH INVESTIGATION THAT A PATIENT WITH A 27MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 9 MONTHS DUE TO RESTRICTED LEAFLET MOTION WITH MODERATE STENOSIS AND REGURGITATION. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND PALPITATIONS. THE TMVR WAS SUCCESSFULLY PERFORMED WITH A 29MM 9755RSL VALVE IN A OPEN PROCEDURE. THE PATIENT WAS TRANSFERRED TO CT-ICU IN STABLE CONDITION. PER MEDICAL RECORDS, PRE-OP ECHO SHOWED ABNORMAL BIOPROSTHETIC MITRAL VALVE WITH MODERATELY INCREASED GRADIENTS (VMAX 2.7 M/S, MEAN GRADIENT 7MMHG. PRE-OP TEE SHOWED MITRAL VALVE WITH RESTRICTED LEAFLET MOTION RESULTING IN A MG 6 MMHG; THERE IS ALSO MODERATE, CENTRAL REGURGITATION OF THE PROSTHETIC VALVE. CONCOMITANTLY, A 21MM 3300TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE, AND TVR REPAIR FOR SEVERE NATIVE TR WITH A 28MM 6200 RINGS.

  Patient problems: Dyspnea

  MAUDE report 23342608 ↗
• InjuryOct 17, 2025Calcified; Calcified

  EDWARDS RECEIVED NOTIFICATION FROM TAIWAN, THAT THIS 67-YEAR-OLD PATIENT WITH A VALVE MODEL 7300TFX27 IMPLANTED IN THE MITRAL POSITION UNDERWENT A VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF AT LEAST SEVEN (7) YEARS AND EIGHT (8) MONTHS DUE TO CALCIFICATION, WHICH LED INTO MITRAL STENOSIS. THE PATIENT PRESENTED WITH FATIGUE BEFORE THE PROCEDURE. A TRANSCATHETER VALVE WAS IMPLANTED IN REPLACEMENT, AND THE PATIENT WAS NOTED AS TO BE SAFE AND STABLE. THE IMPLANT DATE IS ONLY KNOWN AS "2017". THEREFORE, (B)(6) 2017 IS BEING USED TO CALCULATE THE MINIMUM IMPLANT DURATION.

  Patient problems: Fatigue

  MAUDE report 23322035 ↗
• InjuryOct 15, 2025Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 27MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 11 MONTHS DUE TO CALCIFICATION WITH STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE, SHORTNESS OF BREATH, AND SYNCOPE. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS IN RECOVERY AND STABLE CONDITION POST PROCEDURE. PATIENT WAS DISCHARGED ON POD#8.

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

  MAUDE report 23285568 ↗
• InjurySep 16, 2025Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 7300TFX MITRAL VALVE IS UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS , 3 MONTHS DUE TO INCREASED GRADIENTS. PATIENT PRESENTED WITH SHORTNESS OF BREATH. PER MEDICAL RECORDS, TEE DEMONSTRATED ELEVATED MV GRADIENTS (11MMHG) AND WAS PLACED UNDER CONSIDERATION FOR REINTERVENTION PROCEDURE.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 23061710 ↗
• InjurySep 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALE PROCEDURE AFTER AN IMPLANT DURATION OF APPROXIMATELY NINE (9) YEARS AND FIVE (5) MONTHS DUE TO UNKNOWN REASON. THE PROCEDURE WAS PERFORMED WITH A 29MM 9600TFX TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 23058158 ↗
• InjurySep 11, 2025Degraded; Thickening of Material; Degraded; Thickening of Material

  IT WAS REPORTED AND THROUGH INVESTIGATION THAT A PATIENT WITH A 27MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN APPROXIMATELY IMPLANT DURATION OF 7 YEARS, 7 MONTHS DUE TO THICKENED LEAFLETS WITH STENOSIS WITH A MITRAL GRADIENT (MG) OF 16 MM HG. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE PATIENT UNDERWENT TMVR WITH A 26MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS STABLE AT THE END OF THE PROCEDURE.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 23031089 ↗
• InjurySep 11, 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 27MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 5 MONTHS DUE TO SEVERE STENOSIS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11400M VALVE. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH WITH EXERTION. THE PATIENT UNDERWENT REDO-MVR WITH A 27MM 7300TFX VALVE. INTRAOPERATIVELY, THE PREVIOUS SUTURES WERE REMOVED AS WAS THE VALVE. THE PANNUS WAS FURTHER DEBRIDED. THE PATIENT WAS TRANSFERRED TO ICU IN STABLE CONDITION AND WAS DISCHARGED ON POD#5.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 23030962 ↗
• InjurySep 11, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, EIGHT (8) MONTHS DUE TO STENOSIS. THE PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 23029088 ↗
• InjurySep 10, 2025Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 5 MONTHS DUE TO CALCIFICATION. THE PATIENT PRESENTED WITH DYSPNEA. THE PROCEDURE WAS PERFORMED WITH A 29MM 9600TFX TRANSCATHETER VALVE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION POST-PROCEDURE.

  Patient problems: Dyspnea

  MAUDE report 23019456 ↗
• InjurySep 9, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT 27MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE AFTER AN IMPLANT DURATION OF 3 YEARS AND 3 MONTHS DUE TO STENOSIS. THE VALVE WAS REPLACED WITH A 29MM 9755RSL.

  Patient problems: Insufficient Information

  MAUDE report 23006336 ↗