MAUDE Adverse Event Report: ABBOTT MEDICAL Epic Plus; Heart-Valve, Non-Allograft Tissue

Model Number	E200-29M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	04/27/2026
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
Crd_(b)(4) - sh device registry, patient site id: (b)(4).It was reported that on (b)(6) 2026 that a 29mm epic plus mitral valve was chosen for implant.Post-procedure, it was reported that on (b)(6) 2026, patient experienced pericardial effusion and required pericardial drainage.Cardiac tamponade was reported.

• 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: 25635539
• Report Number: 2135147-2026-04371
• Device Sequence Number: 9526302
• Product Code: LWR
• UDI-Device Identifier: 05415067033086
• UDI-Public: (01)05415067033086(17)291116
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/18/2026

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: E200-29M
• Device Catalogue Number: E200-29M
• Device Lot Number: BR00055802
• 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: 06/01/2026
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 06/26/2026
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2025
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 134 LB