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

Model Number	EMAX-25
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.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 max valve was chosen for a pulmonary re-valvulation procedure.When the valve was inserted, it was noted that there was a wire on it, causing contamination of the prosthetic tube used.There was a risk of granuloma formation if a foreign body persists in the surgical site.A new prosthetic tube and another valve were chosen and completed the procedure.There was no delay in the procedure.
Additional Manufacturer Narrative
It was reported that the was noted that there was a wire on it, causing contamination.The valve was returned to abbott and was examined microscopically.The valve was returned attached to the valve holder.All three leaflets were noted to be in a dehydrated state.One small spot of blood was noted on one leaflet.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
N/a.

• 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: 24400653
• Report Number: 2135147-2026-01042
• Device Sequence Number: 10113767
• Product Code: LWR
• UDI-Device Identifier: 05415067045454
• UDI-Public: (01)05415067045454(17)281106
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/30/2026

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-25
• Device Catalogue Number: EMAX-25
• Device Lot Number: BR00049301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• 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