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	Atrial Fibrillation (1729); Hematoma (1884); Hemothorax (1896); Heart Failure/Congestive Heart Failure (4446)
Date of Event	05/01/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
(b)(4) device registry, patient site id: (b)(6) (r1011361401).It was reported that on (b)(6) 2026, a 33mm epic plus mitral valve was chosen for implant.Post-procedure, patient experienced biventricular pump failure.Extracorporeal membrane oxygenation (ecmo) was implanted, and patient was transferred to intensive care unit.Ecmo was explanted on post-operative day (pod) 2 following hemodynamic stability.On (b)(6) 2026, patient experienced post-operative atrial fibrillation and delayed recovery from anesthesia.Computed tomography showed no evidence of acute ischemia.On (b)(6) 2026, patient experienced right-sided hematothorax.Patient received blood transfusion on (b)(6) 2026.Reoperation for hematoma evacuation was performed on (b)(6) 2026.

• 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: 25799492
• Report Number: 2135147-2026-04805
• Device Sequence Number: 18398955
• Product Code: LWR
• UDI-Device Identifier: 05415067033109
• UDI-Public: (01)05415067033109(17)290827
• 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,Followup
• Report Date (Section B): 09/29/2026

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: BR00054543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 07/13/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2025
• 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; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 195 LB