Epic™ E100-23A-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734055536), received between Dec 16, 2020 and Dec 16, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionDec 16, 2020Off-Label Use; Obstruction of Flow; Material Deformation; Off-Label Use; Obstruction of Flow; Material Deformation

  ON (B)(6) 2020, A 23 MM EPIC STENTED PORCINE AORTIC HEART VALVE WAS IMPLANTED IN THE PULMONARY POSITION. WHEN THE PATIENT CAME OFF OF BYPASS, PULMONARY STENOSIS WAS NOTED. THE PATIENT WAS PLACED BACK ON BYPASS AND THE VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER EPIC STENTED PORCINE AORTIC HEART VALVE TO RESOLVE THE EVENT. WHILE INSPECTING THE EXPLANTED VALVE, A PINCHED CREASE AND SOME LEAFLET REDUNDANCY WITHIN IN THE VALVE LEAFLETS. THE PHYSICIAN ALLEGES THAT THE STENOSIS WAS CAUSED BY THE NATIVE LEAFLET OF THE PULMONARY VALVE AND WAS NOT CAUSED BY THE EPIC VALVE AND DID NOT FEEL THIS WAS A VALVE ISSUE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE PATIENT IS RECOVERING AND DOING WELL.

  Patient problems: Stenosis

  MAUDE report 11015431 ↗