Epic™ ESP100-25-00Recalls & reported problems
St. Jude Medical, Inc. · St. Jude Medical Porcine Aortic Supra Bioprosthetic Heart Valve · Class 3 · Implant
All models of Epic (26)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734055659), received between Jul 9, 2018 and Jun 4, 2019 — classified as 2 injuries.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Perivalvular Leak1
Patient problems
- Aortic Insufficiency1
- Aortic Regurgitation1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFORMATION RECEIVED FROM PATIENT DEVICE TRACKING NOTES THAT ON (B)(6) 2019, A 25MM EPIC VALVE WAS NOT IMPLANTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8666302 ↗InjuryJul 9, 2018Perivalvular Leak; Perivalvular Leak
ON (B)(6) 2018, A 25MM EPIC SUPRA VALVE WAS IMPLANTED. AFTER REMOVING THE PATIENT FROM BY-PASS, A POST-IMPLANT TEE SHOWED AORTIC VALVE REGURGITATION AND SIGNIFICANT PARAVALVULAR LEAKAGE. THE PATIENT WAS RETURNED TO BY-PASS AND THE EPIC VALVE WAS REMOVED AND REPLACED WITH A MECHANICAL VALVE. THE USER COMMENTS THE COR-KNOT DID NOT FIRE PROPERLY. THE PATIENT IS REPORTED TO BE STABLE.
Patient problems: Aortic Insufficiency; Aortic Regurgitation
MAUDE report 7671274 ↗
Other heart-valve, non-allograft tissue devices
- INSPIRIS RESILIA AORTIC VALVE 11500AEdwards Lifesciences LLC · Heart-Valve, Non-Allograft Tissue2 deaths404 reports
- INSPIRIS RESILIA AORTIC VALVE 11500AEdwards Lifesciences LLC · Heart-Valve, Non-Allograft Tissue385 reports
- PERCEVAL PVS23Corcym Canada Corp · heart-valve, non-allograft tissue26 deaths337 reports
- MOSAIC® 305C23Medtronic, Inc. · heart-valve, non-allograft tissue327 reports
- MOSAIC® 305C25Medtronic, Inc. · heart-valve, non-allograft tissue2 deaths324 reports
- FREESTYLE® FR995-27Medtronic, Inc. · heart-valve, non-allograft tissue2 deaths318 reports
- FREESTYLE® FR995-29Medtronic, Inc. · heart-valve, non-allograft tissue288 reports
- FREESTYLE® FR99525Medtronic, Inc. · heart-valve, non-allograft tissue2 deaths280 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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