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

Model Number	E200-27M
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 27mm epic plus mitral valve was chosen for a procedure.During procedure, the annulus was sized, but the valve could not be implanted, one of the struts was catching on some excess tissue.A new 27mm epic plus mitral valve was chosen and completed the procedure while patient on bypass.There was some additional time in the procedure and it was unknown if there was a patient effect.
Event or Problem Description
It was reported that on (b)(6) 2026, a 27mm epic plus mitral valve was chosen for a procedure.During procedure, the annulus was sized, but the valve could not be implanted, one of the struts was catching on some excess tissue.A new 27mm epic plus mitral valve was chosen and completed the procedure while patient on bypass.There was some additional time in the procedure and it was unknown if there was a patient effect.
Additional Manufacturer Narrative
An event of one of the struts was catching on some excess tissue was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.No images were provided for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.This includes multiple inspections throughout the valve manufacturing process to ensure the sutures are in place and intact on both the assembled valve and after the valve is placed inside the valve jar.The cause of the reported event could not be conclusively determined.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: 24839285
• Report Number: 2135147-2026-02308
• Device Sequence Number: 6146154
• Product Code: LWR
• UDI-Device Identifier: 05415067033062
• UDI-Public: (01)05415067033062(17)280409
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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: BR00044398
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2024
• 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