EDWARDS MC3 TRICUSPID ANNULOPLASTY RING 4900TRecalls & reported problems
Edwards Lifesciences LLC · Edwards MC3 Tricuspid Annuloplasty Ring · 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 00690103182293), received between Aug 19, 2022 and Aug 19, 2022 — 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
- Heart Block1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 19, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT A 32MM 4900T ANNULOPLASTY RING WAS EXPLANTED AFTER AN IMPLANT DURATION OF FOUR (4) DAYS DUE TO CONDUCTION ABNORMALITIES POST TRICUSPID VALVE REPAIR. AFTER INITIAL RING IMPLANT, THE PATIENT SHOWED SIGNS OF PROGRESSIVE DETERIORATION OF HIS CONDUCTION. SINUS RHYTHM WAS OBSERVED WHEN FIRST COMING OUT OF THE OR, AND THEN 24 HOURS LATER, TYPE A 2ND-DEGREE HEART BLOCK WAS OBSERVED WITH INTERMITTENT COMPLETE HEART BLOCK. THERE WERE SOME CONCERNS THAT THE INFEROMEDIAL ASPECT OF THE MC3 RING MIGHT BE MECHANICALLY TROUBLING THE AV NODE. THEREFORE, THE PATIENT WAS TAKEN TO THE OR TO REPLACE THE RING. INTRAOPERATIVELY, THE MC3 RING WAS VISUALIZED AND FOUND TO BE CREATING A SMALL INDENTATION IN THE ENDOCARDIUM AND MUSCLE AT THE CRUX OF THE HEART INFERIOR TO THE CORONARY SINUS OSTIUM. IT WAS UNABLE TO DISTORT THE RING IN ANY MEANINGFUL WAY TO RELIEVE THE COMPRESSION. THE RING WAS EXPLANTED AND REPLACED WITH A NON-EDWARDS RING WHICH WAS TAILORED TO THE PATIENT'S DYSPLASTIC ANNULUS. THE PROCEDURE WAS UNCOMPLICATED, AND THE PATIENT RHYTHM IMPROVED AFTER THE REMOVAL OF THE CROSS-CLAMP. THE PATIENT TOLERATED THE PROCEDURE WELL AND RETURNED TO THE ICU IN STABLE CONDITION. THIS DEVI
Patient problems: Heart Block
MAUDE report 15261298 ↗
Other RING, ANNULOPLASTY devices
- CG FUTURE™ 638BL32Medtronic, Inc. · RING, ANNULOPLASTY1 death71 reports
- PROFILE 3D® 680R28Medtronic, Inc. · RING, ANNULOPLASTY1 death67 reports
- CG FUTURE™ 638BL30Medtronic, Inc. · RING, ANNULOPLASTY1 death65 reports
- CG FUTURE™ 638RL32Medtronic, Inc. · RING, ANNULOPLASTY59 reports
- 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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