CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL 4450 (REF 4450M30)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103020243), received between Apr 12, 2022 and Apr 12, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 12, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  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. IN THIS CASE, IT WAS LEARNED THAT A 4450 30MM MITRAL RING, IMPLANTED FOR TWO (2) YEARS AND THREE (3) MONTHS, WAS EXPLANTED DUE TO UNKNOWN REASONS. A DEVICE DEFICIENCY WAS NOTED. THE EXPLANTED DEVICE WAS REPLACED WITH A 6900PTFX 27MM BIOPROSTHETIC VALVE. NO OTHER DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 14090704 ↗