CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL 4450 (REF 4450M24)Recalls & reported problems
Edwards Lifesciences LLC · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103020212), received between Jun 21, 2021 and Jun 21, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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
Device problems
- Patient Device Interaction Problem1
Patient problems
- Dyspnea1
- Mitral Valve Stenosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 21, 2021Patient Device Interaction Problem; Patient Device Interaction Problem
EDWARDS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY THAT A 24MM 4450 MITRAL RING WAS EXPLANTED AFTER AN IMPLANT DURATION OF SIX (6) MONTHS DUE TO EXCESSIVE PANNUS RESULTING IN MITRAL STENOSIS. THE PATIENT PRESENTED WITH WORSENING SHORTNESS OF BREATH. THE EXPLANTED RING WAS REPLACED WITH A 25MM 7300TFX VALVE. PER RECEIVED MEDICAL RECORDS, THE PATIENT PRESENTED WITH WORSENING SHORTNESS OF BREATH. THE MITRAL VALVE WAS FOUND TO HAVE A LOT OF PANNUS CLOSE FROM THE RING ONTO THE MITRAL LEAFLETS AND THAT HAD A REDUCED MOBILITY OF THE MITRAL LEAFLET. THE LEAFLET WAS A SMALL SIZE ALSO, BUT THERE WAS SIGNIFICANT INGROWTH OF TISSUE OVER ONTO THE LEAFLET. THE COR KNOTS WERE REMOVED AND THE RING WAS EXCISED. A 25MM 7300TFX VALVE WAS IMPLANTED. THE VALVE SEATED QUITE WELL WITH NO PVL. THE PATIENT WAS TAKEN TO THE ICU IN A STABLE, BUT CRITICAL CONDITION. THE PATIENT WAS DISCHARGED TO REHAB IN STABLE CONDITION ON POD # 5. 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, E
Patient problems: Dyspnea; Mitral Valve Stenosis
MAUDE report 12035134 ↗
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- Tri-Ad™ 900SFC228Medtronic, Inc. · RING, ANNULOPLASTY4 deaths56 reports
- CG FUTURE™ 638BL34Medtronic, Inc. · RING, ANNULOPLASTY51 reports
- Contour 3D® 690R30Medtronic, Inc. · RING, ANNULOPLASTY1 death50 reports
- CG FUTURE™ 638BL28Medtronic, Inc. · RING, ANNULOPLASTY1 death47 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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