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

Model Number	EMAX-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Atrial Fibrillation (1729); Dyspnea (1816); Fatigue (1849); Low Blood Pressure/ Hypotension (1914)
Date of Event	03/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Crd_1032 - sh device registry, patient site id: (b)(6) it was reported that on (b)(6) 2026, a 25mm epic max aortic valve was chosen for implant.It was then reported post-procedure that patient became hypotensive and was subsequently administered medication.It was then reported on 28 march 2026, patient experienced atrial fibrillation with complaints of shortness of breath, palpitations, and feeling weak/tired.Patient heart rate was reported in the 90-100s.Patient was subsequently administered medication and converted to normal sinus rhythm.No additional or prolonged hospitalization was required.Patient status was reported discharged.
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.

• 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: 50733433
• Report Number: 2135147-2026-06124
• Device Sequence Number: 16110489
• Product Code: LWR
• UDI-Device Identifier: 05415067045454
• UDI-Public: (01)05415067045454(17)290211
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: EMAX-25
• Device Catalogue Number: EMAX-25
• Device Lot Number: BR00050855
• 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: 08/17/2026
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 09/11/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2025
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 215 LB