CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTIC 2700 (REF 270027MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00690103021622), received between Mar 15, 2021 and Sep 6, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2024Calcified; Degraded; Device Stenosis; Calcified; Degraded; Device Stenosis

  IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 27MM 2700 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, ELEVEN MONTHS DUE TO CALCIFIED DEGENERATION AND SEVERE STENOSIS. THE VALVE WAS REPLACEMENT WITH A 25MM 11500A VALVE. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND UNDERWENT REDO AVR WITH ASCENDING AORTA REPLACEMENT WITH 30MM GELWEAVE GRAFT AND SEPTAL MYECTOMY. OPERATIVE FINDINGS/TEE SHOWED PROSTHETIC AORTIC VALVE CALCIFIED DEGENERATED WHICH CAUSED SEVERE STENOSIS. AORTA ASCENDING ANEURYSM (ROOT AND ARCH INTACT), HYPERTROPHIC SEPTUM. THE 25MM 11500A VALVE WAS IMPLANTED WITH PLEDGETED NON-EVERTING MATTRESS SUTURES. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO IMMEDIATE COMPLICATIONS AND WAS DISCHARGED ON POD #6. PER HOSPITAL PATHOLOGY REPORT: GROSS EXAM, 3 AORTIC CUSPS ARE MARKEDLY CALCIFIED AND IMMOBILE, THERE IS MILD PANNUS PRESENT. ONE OF THE CUSPS IS TORN. 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 SURVEILL

  Patient problems: Dyspnea

  MAUDE report 20162373 ↗
• InjuryJul 2, 2024Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 2700 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SIX (6) YEARS, SIX (6) MONTHS DUE TO REGURGITATION. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE TAVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 26MM 9755RSL VALVE. THE PATIENT WAS IN STABLE CONDITION AT THE END OF THE PROCEDURE.

  Patient problems: Dyspnea

  MAUDE report 19657346 ↗
• InjuryMay 1, 2023Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 2700 AORTIC VALVE UNDERWENT VALVE IN VALVE PROCEDURE AFTER IMPLANT DURATION OF 7 YEARS 3 MONTHS DUE TO UNKNOWN REASON. THE TAVR PROCEDURE WAS PERFORMED SUCCESSFULLY WITH 26MM 9755RSL TRANSCATHETER VALVE. THE PATIENT POST-PROCEDURE IN RECOVERY.

  Patient problems: Dyspnea; Fatigue; Insufficient Information

  MAUDE report 16850214 ↗
• InjuryMar 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH IMPLANT PATIENT REGISTRY THAT A 27MM 2700 AORTIC VALVE, IMPLANTED IN THE PULMONARY POSITION, UNDERWENT A VALVE-IN-VALVE AFTER AN IMPLANT DURATION OF 22 YEARS, THREE (3) MONTHS DUE TO UNKNOWN REASONS. THE TPVR VALVE WAS REPLACED WITH A 29MM 9600TFX VALVE.

  Patient problems: Insufficient Information

  MAUDE report 11489474 ↗