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

Model Number	EMAX-21
Medical Device Problem Codes	Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
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 implanted in the patient.On (b)(6) 2025, a fracture of the leaflet tip was noted.The valve was explanted and a new 33mm epic max valve was implanted.The patient was originally in critical condition but is now showing signs of recovery and is preparing for discharge.
Additional Manufacturer Narrative
Na.The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Codes removed: health effect- impact code: 4624.Medical device problem code: 4008.
Event or Problem Description
It was reported that on (b)(6) 2025, a 21mm epic max valve was implanted in the patient.On (b)(6) 2025, during the preparation stage a bent of the leaflet tip was noted.The defective device was never used inside of the patient's body.A new 33mm epic max valve was implanted.The patient was originally in critical condition but is now showing signs of recovery and is preparing for discharge.

• 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: 23716540
• Report Number: 2135147-2025-07136
• Device Sequence Number: 8910468
• Product Code: LWR
• UDI-Device Identifier: 05415067045447
• UDI-Public: (01)05415067045447(17)290223
• 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: 2025
• Device Explanted Year: 2025
• 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): 02/19/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: EMAX-21
• Device Catalogue Number: EMAX-21
• Device Lot Number: BR00051269
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown