CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS - MITRAL 6900P (REF 6900P33MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00690103152678), received between Feb 4, 2021 and May 26, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Gradient Increase” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  EDWARDS IMPLANT PATIENT REGISTRY RECEIVED INFORMATION A PATIENT WITH A 33MM 6900P MITRAL VALVE IMPLANTED IN THE TRICUSPID POSITION FOR FOUR (4) YEARS, EIGHT (8) MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO UNKNOWN REASONS. A 29MM 9600TFX TRANSCATHETER VALVE WAS IMPLANTED INSIDE THE 33MM 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 17014447 ↗
• InjuryMay 5, 2023Degraded; Fluid/Blood Leak; Gradient Increase; Difficult to Open or Close; Degraded; Fluid/Blood Leak; Gradient Increase; Difficult to Open or Close

  IT WAS REPORTED THAT A PATIENT WITH A 33MM VALVE IN TRICUSPID POSITION IS BEING EVALUATED FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 8 MONTHS DUE TO LEAFLET THICKENING, MOTION RESTRICTED, HIGH GRADIENT, AND MODERATE REGURGITATION.

  Patient problems: Insufficient Information

  MAUDE report 16882159 ↗
• InjuryMar 21, 2023Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 33MM MITRAL VALVE IS BEING EVALUATED FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 1 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH HF, SOB, AND LOWER EXTREMITY EDEMA.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure; Swelling/ Edema

  MAUDE report 16584719 ↗
• InjuryOct 1, 2021Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  THROUGH THE IMPLANT PATIENT REGISTRY, IT WAS REPORTED THAT A PATIENT WITH A 33MM 6900P MITRAL VALVE IMPLANTED IN THE TRICUSPID POSITION FOR 2 YEARS, 9 MONTHS WAS EXPLANTED DUE TO ENDOCARDITIS. THE DEVICE WAS REPLACED WITH A 31MM 7300TFX VALVE. PATIENT EXPIRED ON POD#4.PER MEDICAL RECORDS, PATIENT ALSO UNDERWENT REPAIR ASCENDING AORTIC PSEUDOANEURYSM WITH HEMASHIELD PATCH, REMOVAL OF WIRELESS PACEMAKER. THE PROSTHETIC VALVE WAS REMOVED AND REPLACED WITH A 31MM 7300TFX VALVE. POST OPERATIVE ECHO CONFIRMED GOOD VALVE FUNCTION. THE PATIENT WAS TRANSFERRED TO THE POSTOPERATIVE CARDIAC SURGICAL INTENSIVE CARE UNIT IN CRITICAL CONDITION. THE PATIENT DEVELOPED DIFFUSE CEREBRAL EDEMA POSTOPERATIVELY AND EXPIRED ON POD#4.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 12566054 ↗
• InjuryMay 10, 2021Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 33MM 6900P MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, TWO (2) MONTHS DUE TO SEVERE MITRAL VALVE STENOSIS. THE PATIENT PRESENTED NYHA CLASS IV. THE TMVR WAS PERFORMED WITH A 29MM 9600TFX VALVE. ON POD #2, THE PATIENT WAS DISCHARGED IN STABLE CONDITION.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 11798717 ↗
• InjuryFeb 4, 2021Calcified; Degraded; Fluid/Blood Leak; Gradient Increase; Calcified; Degraded; Fluid/Blood Leak; Gradient Increase

  THROUGH CLINICAL SAFETY, IT WAS REPORTED THAT A PATIENT WITH A 33MM 6900P MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 14 YEARS DUE TO SEVERE MITRAL REGURGITATION, MILD MITRAL STENOSIS, THICKENING, AND TORN LEAFLET SECONDARY TO CALCIFICATION. THE TMVR WAS PERFORMED WITH A 29MM 9600TFX TRANSCATHETER VALVE. THERE WERE NO COMPLICATIONS NOTED. THE PATIENT WAS TRANSFERRED TO THE ICU IN STABLE CONDITION POST PROCEDURE. THE PATIENT WAS DISCHARGED ON POD #4 IN STABLE CONDITION.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 11283004 ↗