MAUDE Adverse Event Report: ABBOTT MEDICAL Epic Max Valve (Aortic); Heart-Valve, Non-Allograft Tissue

Model Number	EMAX-21
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Atrial Fibrillation (1729); Atrial Flutter (1730); Cardiac Arrest (1762); Dyspnea (1816); Endocarditis (1834); Fever (1858); Low Blood Pressure/ Hypotension (1914); Pseudoaneurysm (2605)
Date of Event	11/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Clinical information: (b)(4) - sh device registry, patient site id: site id- (b)(6) ((b)(4)).It was reported that on (b)(6) 2025, a 21mm epic max valve was implanted in the patient.On the 5th post operative day, the patient presented with persistent atrial fibrillation with rapid ventricular responses that was difficult to control.The patient required combination of high dose beta blockers and medications.The patient subsequently progressed to common atrial flutter.The patient got discharged with anticoagulation and a electrical cardioversion was considered.The flutter resolved spontaneously.

• 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 ; +1(651)756-5400
• MDR Report Key: 24844277
• Report Number: 2135147-2026-02303
• Device Sequence Number: 5664104
• Product Code: LWR
• UDI-Device Identifier: 05415067045447
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: BR00043777
• 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: 03/16/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2023
• 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: Disability; Life Threatening; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 198 LB