MAUDE Adverse Event Report: Abbott Medical Epic Plus; Heart-Valve, Non-Allograft Tissue

Model Number	E200-31M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Arrhythmia (1721); Atrial Fibrillation (1729); Bradycardia (1751); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Respiratory Insufficiency (4462)
Date of Event	06/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Crd_1032 - sh device registry, patient site id: (b)(6), (b)(4).It was reported that on (b)(6) 2026, a 31mm epic plus mitral valve was chosen for implant.During procedure, patient exhibited acute anemia and required 2 packed red blood cells (prbcs) transfusions.Post-procedure, patient developed right ventricular dysfunction when coming off of cardiopulmonary bypass and required inotropic support.It was reported during hospitalization, patient experienced continued anemia, multiple episodes of arrhythmia with tachy-bradycardia syndrome, episodes of atrial fibrillation and asystole requiring pacing, post-operative vasoplegia, and acute respiratory insufficiency post-extubation.Patient received three more prbcs, a permanent pacemaker implant on (b)(6) 2026, vasopressor therapy, and high-flow nasal cannula (hfnc) and continuous positive airway pressure (cpap).Patient was weaned off vasopressors by (b)(6) 2026.Patient was weaned to nasal cannula on (b)(6) 2026 and discharged on room air.
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 Plus
• 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 #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 50175468
• Report Number: 2135147-2026-05386
• Device Sequence Number: 12822725
• Product Code: LWR
• UDI-Device Identifier: 05415067033093
• UDI-Public: (01)05415067033093(17)290805
• 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): 08/07/2026

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: E200-31M
• Device Catalogue Number: E200-31M
• Device Lot Number: 10965008
• 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: 07/13/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2025
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 127 LB