CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS - MITRAL 6900P (REF 6900P29MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00690103152654), received between Feb 9, 2021 and Aug 4, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Device Stenosis” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED A PATIENT WITH A 29MM 6900P MITRAL VALVE IMPLANTED EIGHT (8) YEARS, SIX (6) MONTHS, IS BEING EVALUATED FOR VALVE-IN-VALVE PROCEDURE DUE TO STENOSIS. PATIENT PRESENTED WITH SHORTNESS OF BREATH AND DIZZINESS.

  Patient problems: Dizziness; Dyspnea; Insufficient Information

  MAUDE report 22709945 ↗
• InjuryJun 12, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 6900P MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 6 MONTHS DUE TO SEVERE STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND LOWER EXTREMITY EDEMA. THE TMVR WAS PERFORMED WITH A 29MM 9600TFX TRANSCATHETER VALVE. THE PATIENT WAS STABLE POST PROCEDURE. THE PATIENT IS ON ELIQUIS.

  Patient problems: Dyspnea; Swelling/ Edema

  MAUDE report 22195000 ↗
• InjuryApr 3, 2025Calcified; Calcified

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 29MM 6900P MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 5 MONTHS DUE TO CALCIFICATION AND STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE EXPLANTED DEVICE WAS REPLACED WITH A 27MM 11400M MITRAL VALVE. THE PATIENT WAS IN RECOVERY POST PROCEDURE AND DISCHARGED ON POD #4. PER MEDICAL RECORDS, TEE DEMONSTRATED SEVERELY THICKENED AND CALCIFIED POSTERIOR LEAFLET WITH SEVERE STENOSIS. PER PATHOLOGY REPORT, SEMILUNAR LEAFLETS OF YELLOW-TAN MODERATELY CALCIFIED TISSUE WAS NOTED. 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 I

  Patient problems: Dyspnea

  MAUDE report 21762663 ↗
• InjurySep 19, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A 29MM 6900P VALVE IN THE MITRAL POSITION IS UNDERWENT VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 4 MONTHS DUE TO STENOSIS. THE TMVR WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 20260182 ↗
• InjuryJul 23, 2024Calcified; Difficult to Open or Close; Device Stenosis; Calcified; Difficult to Open or Close; Device Stenosis

  IT WAS LEARNED FROM IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 29MM 6900P VALVE IN THE MITRAL POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS AND TEN (10) MONTHS DUE TO MITRAL STENOSIS RESULTING FROM LEAFLET CALCIFICATION AND IMMOBILITY. A TAVR PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. THE PATIENT PRESENTED TO THE HOSPITAL WITH DYSPNEA. PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION POST-OPERATIVELY AND WAS DISCHARGED ON POD #2. 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

  Patient problems: Dyspnea

  MAUDE report 19812252 ↗
• InjuryMay 23, 2024Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY THAT A 29MM 6900P MITRAL VALVE, WAS EXPLANTED AFTER AN IMPLANT DURATION OF SIX (6) YEARS, ELEVEN (11) MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11400M VALVE. THE PATIENT WAS TAKEN TO 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: Dyspnea; Insufficient Information

  MAUDE report 19387631 ↗
• InjuryJan 30, 2023Gradient Increase; Gradient Increase

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED THAT A PATIENT WITH A 29MM MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 8 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH HF AND SOB. THE TMVR WAS PERFORMED WITH A 29MM TRANSCATHETER VALVE. THE PATIENT EXPIRED ON POD #17.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 16265276 ↗
• InjuryDec 21, 2022Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  EDWARDS RECEIVED INFORMATION A PATIENT WITH AN UNKNOWN EDWARDS SURGICAL VALVE IMPLANTED FOR AN UNKNOWN IMPLANT DURATION UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO UNKNOWN REASONS. A 29MM 9600TFX TRANSCATHETER VALVE WAS SUCCESSFULLY IMPLANTED INSIDE THE SURGICAL VALVE.

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

  MAUDE report 16026069 ↗
• InjuryMar 22, 2021Calcified; Degraded; Gradient Increase; Patient Device Interaction Problem; Calcified; Degraded; Gradient Increase; Patient Device Interaction Problem

  IT WAS REPORTED THAT A 29MM 6900P MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS DUE TO 'EARLY' VALVE DEGENERATION LEADING TO SEVERE MITRAL STENOSIS. THE EXPLANTED VALVE WAS REPLACED WITH A 31MM NON-EDWARDS VALVE. PLANNED AVR AND TV REPAIR WERE ALSO PERFORMED WITHIN THE SAME SURGERY. THE PATIENT RECEIVED BLOOD PRODUCTS INTRAOPERATIVELY. THE PATIENT WAS IN COMPLETE HEART BLOCK AT THE END OF THE CASE. ON POD #1, A DUAL-CHAMBER PACEMAKER WAS IMPLANTED. THE PATIENT WAS DISCHARGED ON POD #7.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 11546051 ↗
• InjuryFeb 25, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED: AS PER SURGEON RESPONSE, DID NOT FEEL THE VALVE FAILED PREMATURELY.

  Patient problems: Insufficient Information

  MAUDE report 11380741 ↗
• InjuryFeb 24, 2021Calcified; Gradient Increase; Calcified; Gradient Increase

  EDWARDS RECEIVED NOTIFICATION THAT THIS PATIENT WITH A 29MM 6900P MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 15 YEARS, TWO (2) MONTHS DUE TO CALCIFICATION LEADING TO MITRAL STENOSIS (MEAN GRADIENT 12MMHG). AS REPORTED, BEFORE THE PROCEDURE, THE PATIENT EXPERIENCED SHORTNESS OF BREATH. A 26MM SAPIEN 3 ULTRA TRANSCATHETER VALVE WAS SUCCESSFULLY IMPLANTED WITHIN THE SURGICAL EDWARDS VALVE. THE PATIENT WAS NOTED AS TO BE IN GOOD CONDITION AFTER THE PROCEDURE, WITHOUT PVL, BUT THERE WAS A GRADIENT (2.5 M/S) ACROSS THE LVOT DUE TO SLIGHT OBSTRUCTION. IT IS UNKNOWN WHETHER OR NOT THE DEVICE FAILED PREMATURELY.

  Patient problems: Dyspnea

  MAUDE report 11373463 ↗
• InjuryFeb 17, 2021Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 6900P MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF FIVE (5) YEARS DUE TO SEVERE MITRAL REGURGITATION. PER THE MEDICAL RECORDS, THE PATIENT PRESENTED WITH ACUTE ON CHRONIC DIASTOLIC/VALVULAR CHF. THE TMVR WAS SUCCESSFULLY PERFORMED WITH A 29MM 9600TFX. ON POD #2, THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 11340151 ↗
• InjuryFeb 9, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY, IT WAS REPORTED THAT A 29MM 6900P MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF ONE (1) YEAR, 10 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 6900PTFX 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 11304695 ↗