MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC PLUS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	E200-29M
Medical Device Problem Codes	Incomplete Coaptation (2507); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Dyspnea (1816); Mitral Valve Stenosis (1965); Thrombosis/Thrombus (4440); Insufficient Information (4580)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2025, a 29mm epic plus mitral valve was implanted in the patient.On an unknown date, it was noted that the valve got failed and a pacemaker was implanted.
Additional Manufacturer Narrative
An event of thrombus, leaflet incomplete coaptation, structural valve deterioration and patient effects of shortness of breath, stenosis approximately 3 months post-procedure was reported.Information from the field indicated that upon explant, the valve showed clear thrombosis - immobile leaflets.There were no calcifications, perforations/tears, or vegetations seen.Path report consistent with acute and chronic thrombus.The device was not returned to abbott for investigation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the available information, the cause of thrombus formation, leaflet incomplete coaptation, structural valve deterioration could not be conclusively determined.The reported surgical intervention was results of case specific circumstances as valve explanted surgically and permanent pacemaker was implanted.The reported hospitalization was required as patient needed second surgery.
Event or Problem Description
It was reported that on (b)(6)2025, a 29mm epic plus mitral valve was implanted in the patient.The patient started to have shortness of breath starting (b)(6)2025.The echocardiogram (echo) showed thrombosis with increasing mitral valve gradients.The valve got explanted.The explanted valve showed clear thrombosis, immobile leaflets.There were no calcifications, perforations/tears, or vegetations were seen.The path report consistent with acute and chronic thrombus.The patient had a pacemaker was implanted.The patient was reported stable and discharged.

• 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 ; 6517565400
• MDR Report Key: 24349420
• Report Number: 2135147-2026-00945
• Device Sequence Number: 4952567
• Product Code: LWR
• UDI-Device Identifier: 05415067033086
• UDI-Public: (01)05415067033086(17)280805
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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: 10489078
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2024
• 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: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female