SJM™ Mechanical Heart Valve M-101 (REF 29M-101)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734006521), received between Jul 12, 2022 and Jul 12, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Perivalvular Leak” (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 16, 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.

• InjuryJul 12, 2022Perivalvular Leak; Perivalvular Leak

  AT AGE (B)(6), AN OPEN MITRAL COMMISSUROTOMY WAS PERFORMED DUE TO RHEUMATIC MITRAL STENOSIS. AT AGE (B)(6), THE PATIENT UNDERWENT A MITRAL VALVE REPLACEMENT (MVR), AND A 29MM SJM MECHANICAL HEART VALVE IMPLANTED DUE TO INFECTIOUS ENDOCARDITIS. AT AGE (B)(6), A PARAVALVULAR LEAK (PVL) WAS NOTED, AS WELL AS AORTIC STENOSIS AND REGURGITATION (ASR) DETERIORATION. A DOUBLE VALVE REPLACEMENT WAS PERFORMED FOR THE AORTIC VALVE AND THE MITRAL VALVE. FOR THE MITRAL VALVE REPLACEMENT, THE 29MM SJM MECHANICAL HEART VALVE WAS EXPLANTED AND REPLACED WITH A 25MM NON-ABBOTT TISSUE VALVE. FOR THE AORTIC REPLACEMENT, A 21MM NON-ABBOTT TISSUE VALVE WAS IMPLANTED. ONE YEAR AFTER THE DOUBLE VALVE REPLACEMENT SURGERY, PROSTHETIC VALVE ENDOCARDITIS (PVE) OCCURRED, AND THE PATIENT WAS TREATED CONSERVATIVELY. NINETEEN YEARS THE DOUBLE VALVE REPLACEMENT SURGERY AT AGE (B)(6), THERE WAS STRUCTURAL VALVE DETERIORATION (SVD) OF BOTH NON-ABBOTT VALVES AND CARDIAC INSUFFICIENCY. THE PATIENT UNDERWENT ANOTHER SURGERY, AND THE MITRAL VALVE, AORTIC VALVE, AND TRICUSPID VALVE WERE REPLACED. A 27MM SJM EPIC VALVE WAS IMPLANTED IN THE MITRAL POSITION, A 23MM SJM EPIC VALVE WAS IMPLANTED IN THE AORTIC POSITION, AND A

  Patient problems: Insufficient Information

  MAUDE report 14991195 ↗