CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS - MITRAL 6900P (REF 6900P27MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00690103152647), received between Apr 30, 2021 and Aug 29, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2025Device Dislodged or Dislocated; Device Stenosis; Device Dislodged or Dislocated; Device Stenosis

  IT WAS REPORTED AND THROUGH ADDITIONAL INFORMATION THAT A PATIENT WITH A 27MM 6900P MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 3 MONTHS DUE TO SEVERE STENOSIS, SEVERE TRANSVALVULAR REGURGITATION WITH PARTIAL DEHISCENCE. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH WITH EXERTION. THE PROCEDURE WAS PERFORMED SUCCESSFULLY WITH A 26MM9750TFX TRANSCATHETER VALVE. PER TEE ((B)(6) 2025): SEVERE MS, MMG 9, MVA 0.8, MOD/SEVERE (3+) TRANSVALVULAR MR, AT MOST TRACE PARAVALVULAR.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 22926671 ↗
• InjuryAug 2, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 27MM 6900P MITRAL VALVE UNDERWENT A VALVE-IN-VALE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS AND FIVE (5) MONTHS DUE TO CENTRAL REGURGITATION. THE PATIENT PRESENTED WITH HEART FAILURE AND DYSPNEA. 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: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 22695576 ↗
• InjuryJul 14, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A 6900P 27MM PERICARDIAL MITRAL VALVE WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 2 MONTHS DUE TO STENOSIS. A 26MM EDWARDS S3 ULTRA TRANSCATHETER VALVE WAS IMPLANTED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 22494848 ↗
• InjuryJan 31, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 6900P MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 11 MONTHS DUE TO STENOSIS AND REGURGITATION. THE PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 21286402 ↗
• InjuryOct 9, 2024Device Stenosis; Device Stenosis

  IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY THAT A MODEL 6900P 27MM MITRAL VALVE WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 6 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SOB. A 9755RSL 26MM TRANSCATHETER VALVE WAS IMPLANTED. 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 20408547 ↗
• InjuryAug 23, 2024Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 27MM 6900P MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, FIVE (5) MONTHS DUE TO THICKENED/RESTRTICTED MOTION LEAFLETS WITH CALCIFICATION. PATIENT PRESENTED WITH SHORTNESS OF BREATH AND FATIGUE. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11400M MITRIS RESILIA MITRAL VALVE. PATIENT WAS STABLE AND WAS DISCHARGED ON POD# 9. PER PATHOLOGY, LEAFLETS NOTED TO BE STIFFENED YET MOBILE, WITH MULTIPLE CALCIFICATIONS. THIS IS A 70-YEAR-OLD PATIENT

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 20047664 ↗
• InjuryAug 3, 2024Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS LEARNED FROM IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 27MM 6900P IN THE MITRAL POSITION UNDERWENT A VALVE EXPLANT AFTER AN IMPLANT DURATION OF SIX (6) YEARS, SEVEN (7) MONTHS DUE TO EXTENSIVE CALCIFICATIONS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11400M VALVE. PER PATHOLOGY REPORTS, CALCIFICATIONS HAVE BEEN DETECTED ON THE CUSPS OF THE BIOPROSTHETIC VALVE, AND AREAS OF VEGETATION HAVE ALSO BEEN IDENTIFIED. THIS 79-YEAR-OLD MALE 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: Insufficient Information

  MAUDE report 19901717 ↗
• InjuryJul 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH EDWARDS IMPLANT PATIENT REGISTRY, IT WAS LEARNED A PATIENT WITH A 27MM 6900P MITRAL VALVE IMPLANTED SEVEN (7) YEARS, SEVEN (7) MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO UNKNOWN REASONS. A 26MM 9750TFX TRANSCATHETER VALVE WAS IMPLANTED INSIDE THE 27MM VALVE. PATIENT POST-OPERATIVE STATUS NOTED AS IN 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 17410668 ↗
• InjuryMar 21, 2023Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 27MM SURGICAL VALVE WAS IMPLANTED IN THE MITRAL POSITION FOR UNKNOWN PERIOD OF TIME UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO UNKNOWN REASONS. THE PROCEDURE WAS PERFORMED SUCCESSFULLY WITH A 26MM 9750TFX TRANSCATHETER VALVE.

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

  MAUDE report 16588121 ↗
• InjuryDec 28, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT A 27MM (B)(4) BIOPROSTHETIC MITRAL VALVE, IMPLANTED FOR 12 YEARS AND SEVEN (7) MONTHS, WAS EXPLANTED DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH A 29MM (B)(4) BIOPROSTHETIC VALVE. THE IMPLANTATION DATA CARD INDICATED THAT THE DEVICE EXPLANT WAS DUE TO DEFICIENCY OF THE ORIGINAL DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 13101070 ↗
• InjuryApr 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT 27MM 6900P MITRAL VALVE WAS EXPLANTED AFTER AN UNKNOWN IMPLANT DURATION DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A ST. JUDE EPIC MITRAL VALVE. NO OTHER DETAILS HAVE BEEN PROVIDED

  Patient problems: Insufficient Information

  MAUDE report 11757785 ↗