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

Model Number	EMAX-21
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Stroke/CVA (1770); Pulmonary Edema (2020); Respiratory Insufficiency (4462)
Date of Event	06/17/2026
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 21mm epic max aortic valve was chosen for implant.The patient also received a 25mm epic plus mitral valve for a concomitant double valve replacement procedure.The procedure was uneventful.Following protamine administration, patient developed severe left ventricular dysfunction and was placed on extracorporeal membranous oxygenation (ecmo).It was then reported on (b)(6) 2026, patient presented with respiratory failure of multifactorial origin, initially secondary to acute pulmonary edema and subsequently secondary to ventilator-associated pneumonia.A tracheostomy was performed and patient was administered antibiotics.Patient was weaned off of ecmo on post-op day 8, (b)(6) 2026.On (b)(6) 2026, patient experienced a slow awakening, an urgent computed tomography (ct) scan revealed findings consistent with ischemic stroke of subacute evolution in the territory of the right posterior cerebral artery.A magnetic resonance imaging (mrf) performed 5 days later showed signs of hemorrhagic transformation.It was reported the patient had a good neurological outcome and was discharged with the need for physiotherapy.
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: 50733677
• Report Number: 2135147-2026-06131
• Device Sequence Number: 18783875
• Product Code: LWR
• UDI-Device Identifier: 05415067045447
• UDI-Public: (01)05415067045447(17)280522
• 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: 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
• 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-21
• Device Catalogue Number: EMAX-21
• Device Lot Number: BR00046090
• 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
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2024
• 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: Life Threatening; Disability; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 160 LB