CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTIC 2700 (REF 270029MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103021639), received between Mar 9, 2021 and Feb 24, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Degraded” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 29MM AORTIC VALVE WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 8 MONTHS DUE TO UNKNOWN REASONS. A 29MM TRANSCATHETER VALVE WAS IMPLANTED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 16438583 ↗
• InjuryMar 9, 2021Degraded; Fluid/Blood Leak; Gradient Increase; Perivalvular Leak; Off-Label Use; Degraded; Fluid/Blood Leak; Gradient Increase; Perivalvular Leak; Off-Label Use

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 2700 AORTIC VALVE, IMPLANTED IN THE PULMONIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF NINE (9) YEARS, TWO (2) MONTHS DUE TO SEVERE DEGENERATION LEADING TO SEVERE PULMONARY STENOSIS, SEVERE PULMONARY REGURGITATION, AND PERIVALVULAR LEAK (PVL). THE TPVR WAS PERFORMED WITH A 29MM 9600TFX TRANSCATHETER VALVE SUCCESSFULLY. THE PATIENT WAS TRANSFERRED TO RECOVERY AREA IN HEMODYNAMICALLY STABLE CONDITION.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 11447114 ↗