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	Atrial Fibrillation (1729); Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130)
Date of Event	04/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Crd (b)(4)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.Intraoperatively, patient experienced multiple episodes of ventricular fibrillation when coming off of cardiopulmonary bypass.Defibrillation was required and patient was put back on bypass.Patient continued to have a few small runs ventricular fibrillation but were self-limited.Post-procedure, patient experienced a bleeding event and over 200cc of fluid drained from chest tube in first hour.Patient was also hypotensive.Medication and 2 units of cryoprecipitate were administered.It was later reported on 25 april 2026, patient cardiac rhythm was going in and out of atrial fibrillation with heart rate in the 90-120 bpm, though remained asymptomatic.Patient self-converted back to normal sinus rhythm and intravenous medication was administered.
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: 50734262
• Report Number: 2135147-2026-06139
• Device Sequence Number: 10620670
• Product Code: LWR
• UDI-Device Identifier: 05415067045454
• UDI-Public: (01)05415067045454(17)290521
• 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: BR00052574
• 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: 08/19/2026
• 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: 05/22/2025
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 239 LB