MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC MAX VALVE (AORTIC); HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	EMAX-21
Medical Device Problem Codes	Incomplete Coaptation (2507); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
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) 2025, a 21mm epic max valve was chosen for a aortic valve replacement (avr) procedure.The sizing was performed confirmed that there were no issues.The annular dimensions of the native valve was 23mm.When the bioprosthetic valve was deployed, one of the leaflets was found to be flipped.The holder was removed, and the leaflet was touched with forceps, but it seemed to have taken a set, so its use was discontinued.The valve was replaced with a 19 mm epic max valve and the procedure was successfully completed while patient on bypass.The operative time was prolonged but the patient was fine.The patient was reported stable.
Event or Problem Description
It was reported that on 15 dec 2025, a 21mm epic max valve was chosen for a aortic valve replacement (avr) procedure.The sizing was performed confirmed that there were no issues.The annular dimensions of the native valve was 23mm.When the bioprosthetic valve was deployed, one of the leaflets was found to be flipped.The holder was removed, and the leaflet was touched with forceps, but it seemed to have taken a set, so its use was discontinued.The valve was replaced with a 19 mm epic max valve and the procedure was successfully completed while patient on bypass.The operative time was prolonged but the patient was fine.The patient was reported stable.
Additional Manufacturer Narrative
It was reported that when the bioprosthetic valve was deployed one of the leaflets was found to be flipped.The holder was removed, and the leaflet was touched with forceps, but it seemed to have taken a set, so its use was discontinued.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received and without the device, the cause of the reported incident 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 MAX VALVE (AORTIC)
• 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: 24019769
• Report Number: 2135147-2026-00180
• Device Sequence Number: 21471450
• Product Code: LWR
• UDI-Device Identifier: 05415067045447
• UDI-Public: (01)05415067045447(17)290216
• 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): 02/26/2026

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: EMAX-21
• Device Catalogue Number: EMAX-21
• Device Lot Number: BR00050893
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2025
• 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