Epic™ ESP100-23-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734055642), received between May 9, 2019 and Nov 22, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Incomplete Coaptation” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 2024Incomplete Coaptation; Intravalvular regurgitation; Incomplete Coaptation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2024 A 23MM EPIC SUPRA VALVE WAS CHOSEN FOR IMPLANT DURING AN AORTIC VALVE REPLACEMENT. THE PHYSICIAN SIZED FOR THE VALVE, PLACED SUBANNULAR MATTRESS SUTURES, AND PARACHUTED THE VALVE INTO THE ANNULUS. THE VALVE WAS SITTING WELL AND LOOKED FUNCTIONAL. AS THE PATIENT CAME OFF OF CARDIOPULMONARY BYPASS, THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED A MODERATE CENTRAL REGURGITATION. AS THE PATIENT WAS HEMODYNAMICALLY STABLE, THE PATIENT WAS WEANED OFF BYPASS, STERNOTOMY WAS CLOSED, AND PATIENT WAS SENT TO CRITICAL CARE UNIT. ON THE MORNING OF (B)(6) 2024, THE TRANSTHORACIC ECHOCARDIOGRAM (TTE) STILL SHOWED MODERATE REGURGITATION. THE PATIENT WAS TAKEN BACK TO SURGERY. A TEE SHOWED THAT THE MODERATE REGURGITATION HAD PROGRESSED TOO SEVERE. THE VALVE WAS EXPLANTED AND REPLACED WITH A 23MM NON-ABBOTT VALVE. THE ECHO SHOWED TRACE REGURGITATION. THE PATIENT WAS REPORTED TO BE DOING WELL. THE PHYSICIAN BELIEVED THAT THERE WAS SOMETHING UNUSUAL WITH THE LEAFLETS OF THE 23MM EPIC SUPRA VALVE NOT COAPTING PROPERLY.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 20765369 ↗
• InjuryMay 9, 2019Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 2019, A 23MM EPIC SUPRA VALVE WAS SELECTED FOR IMPLANT. AFTER IMPLANT, THE PHYSICIAN OBSERVED THAT ONE OF THE LEAFLETS WAS NOT CLOSING PROPERLY, RESULTING IN INCOMPLETE COAPTATION. THE PHYSICIAN ATTEMPTED UNSUCCESSFULLY TO FREE THE LEAFLET BY ROTATING THE VALVE WITH THE ROTATOR TO ASSESS IF UNDERLYING NATIVE TISSUE WAS INTERFERING WITH COAPTATION. THE SITE DID NOT VERIFY WHETHER OR NOT ANY SUCH UNDERLYING NATIVE TISSUE WAS PRESENT. THE VALVE WAS EXPLANTED, AND A REPLACEMENT 23MM EPIC SUPRA VALVE WAS IMPLANTED. PER SITE, THE EXPLANTED VALVE HAD BEEN RINSED AND HANDLED AT ALL TIMES ACCORDING TO THE IFU. THE PATIENT HAS BEEN DISCHARGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8595122 ↗