MAUDE Adverse Event Report: Abbott Medical Epic Plus; Heart-Valve, Non-Allograft Tissue

Model Number	E200-27M
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, a 27mm epic plus mitral valve was implanted in the mitral valve position.Due to perivalvar leak (pvl), it was reimplanted, but no improvement was achieved.Subsequently, a 25mm epic plus mitral valve was implanted, and the procedure was completed.The patient was reported stable.
Additional Manufacturer Narrative
The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

• Brand Name: Epic Plus
• Common Device Name: Heart-Valve, Non-Allograft Tissue
• Manufacturer (Section D): Abbott Medical; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): St. Jude Medical Ltda. Reg#3001883144; 1301rua profvieira demendonça; bairro engenho nogueira 31.31 0-26; BR 31.310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 50817186
• Report Number: 2135147-2026-06290
• Device Sequence Number: 10210949
• Product Code: LWR
• UDI-Device Identifier: 05415067033062
• UDI-Public: (01)05415067033062(17)291009
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: E200-27M
• Device Catalogue Number: E200-27M
• Device Lot Number: BR00055044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown