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

Model Number	E200-33M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Pleural Effusion (2010); Unspecified Tissue Injury (4559)
Date of Event	05/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) - sh device registry, patient site id: (b)(6).It was reported that on (b)(6) 2026, a 33mm epic plus mitral valve was chosen for redo-surgical mitral valve replacement.Post-intervention, patient experienced pleural effusion, requiring a pleural tap on (b)(6) 2026, draining 700 ml of serous fluid, and received two units of red packed blood cells transfusion.Patient also developed subcutaneous emphysema post-intervention, subsequently, bilateral chest tubes were inserted on (b)(6) 2026.It was later reported on 31 may 2026 that patient experienced acute coronary syndrome in a constellation with non-st elevation myocardial infarction (nstemi).Patient had elevated troponin levels.A coronary angiography performed on (b)(6) 2026 revealed no hemodynamically significant stenoses.
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 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: 50897587
• Report Number: 2135147-2026-06499
• Device Sequence Number: 18830947
• Product Code: LWR
• UDI-Device Identifier: 05415067033109
• UDI-Public: (01)05415067033109(17)291026
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/25/2026

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: E200-33M
• Device Catalogue Number: E200-33M
• Device Lot Number: BR00055239
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2025
• 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: Disability; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 138 LB