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	Angina (1710); Atrial Fibrillation (1729); Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)
Date of Event	06/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Crd (b)(4) device registry, patient site id: us0202 - 3851 (b)(6).It was reported that on (b)(6) 2026, a 25mm epic max aortic valve was chosen for implant.During procedure, patient became hypotensive.Post-procedure, patient experienced bleeding from aortic patch and subsequently received blood product transfusions and protamine.Medication was also administered to treat continued hypotension.It was then reported on (b)(6) 2026, patient complained of increased chest pain.Electrocardiogram reported new onset atrial fibrillation, though patient remained hemodynamically stable.Medication, amiodarone, was administered and patient converted back to normal sinus rhythm.The patient's post-operative course included intermittent in and out atrial fibrillation and a self-limited run of ventricular tachycardia on (b)(6) 2026.Medication was adjusted and metoprolol was increased and replete electrolytes.Patient was discharged home in normal sinus rhythm.
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: 50734352
• Report Number: 2135147-2026-06140
• Device Sequence Number: 10662462
• Product Code: LWR
• UDI-Device Identifier: 05415067045454
• UDI-Public: (01)05415067045454(17)290608
• 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
• Report Date (Section B): 09/11/2026

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: BR00052993
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2025
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 213 LB