MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC PLUS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	E200-25M
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that on (b)(6) 2026, a 25mm epic plus mitral valve was chosen for a procedure.The annular dimensions of the native valve was approximately 32¿33mm.During the procedure, a mild to moderate central leak was identified on transesophageal echocardiography, and the valve was explanted and replaced with a 25mm sjm masters series valve expanded cuff valve while patient on bypass.There was a delay, but it had no impact on the patient¿s outcome.The patient was reported stable.
Event or Problem Description
It was reported that on (b)(6) 2026, a 25mm epic plus mitral valve was chosen for a procedure.The annular dimensions of the native valve was approximately 32¿33mm.During the procedure, a mild to moderate central leak was identified on transesophageal echocardiography, and the valve was explanted and replaced with a 25mm sjm masters series valve expanded cuff valve while patient on bypass.There was a delay, but it had no impact on the patient¿s outcome.The patient was reported stable.
Additional Manufacturer Narrative
An event of mild to moderate central leak during procedure was reported.A returned device assessment could not be performed as the device was not returned for analysis.Based on the limited information received, the cause of the reported central regurgitation could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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 ; 6517565400
• MDR Report Key: 24482535
• Report Number: 2135147-2026-01286
• Device Sequence Number: 14725479
• Product Code: LWR
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 05/07/2026

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: E200-25M
• Device Catalogue Number: E200-25M
• Device Lot Number: BR00045869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2024
• 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