Epic™ ESP100-21-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734055635), received between Jun 16, 2021 and Jun 16, 2021 — classified as 1 injury.

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

• InjuryJun 16, 2021Obstruction of Flow; Biocompatibility; Obstruction of Flow; Biocompatibility

  IT WAS REPORTED THAT AN (B)(6) YEAR OLD PATIENT IMPLANTED WITH AN EPIC SUPRA VALVE W/FLEXFIT ON (B)(6) 2021, PRESENTED WITH SYMPTOMS OF CONGESTIVE HEART FAILURE (CHF) REPORTING DYSPNEA, REGURGITATION, AND HIGH GRADIENTS DURING A FOLLOW-UP APPOINTMENT IN THE CLINIC. A CLOT WAS CONFIRMED ON THE VALVE. AT THE DISCOVERY OF THE THROMBUS, THE PATIENT WAS NOT ON ANY ANTICOAGULANT OR ANTIPLATELET THERAPY. THE PATIENT WAS PUT ON HEPARIN AND THEN SWITCHED TO COUMADIN. THE PHYSICIAN REPORTED THE VALVE REMAINED IMPLANTED. THE PATIENTS MEAN GRADIENT HAS DECREASED INTO THE 20S. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure; Thrombosis/Thrombus

  MAUDE report 12013737 ↗