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

Model Number	E200-29M
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Dyspnea (1816); Thrombosis/Thrombus (4440)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 29mm epic plus mitral valve was implanted 18 months ago.On (b)(6) 2025, the patient presented with shortness of breath.The transesophageal echocardiogram (tee) and computed tomography imaging showed thrombus.On (b)(6) 2025, the valve got explanted and a new non-abbott valve was implanted.The patient was reported stable and doing well.
Additional Manufacturer Narrative
The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
Explant about 18 months post-implant due to shortness of breath and thrombosis was reported.The valve was returned to abbott for investigation.The investigation in the returned valve showed tears in the sewing cuff.The outflow surface of cusp 1 was covered in its entirety by adherent brown material which limits the cusp mobility.There was a horizontal fold in the free edge of the cusp, creating incomplete coaptation.On the inflow surface there was a 4 x 4 mm focus of adherent brown material.There was patchy adherent brown material on the inflow and outflow surfaces of cusp 3 which do not affect the cusp mobility.There was patchy pannus formation limited to the sewing cuff.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 reported shortness of breath is likely related to impaired valve function due to organizing fibrin thrombus and adherent material limiting cusp mobility, along with a fold in the free edge contributing to incomplete coaptation.However, the cause of the reported thrombus formation could not be conclusively determined.The cause of pannus formation could not be determined.The reported hospitalization and surgical intervention were results of case specific clinical circumstances related to the valve explant.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that a 29mm epic plus mitral valve was implanted 18 months ago.On (b)(6) 2025, the patient presented with shortness of breath.The transesophageal echocardiogram (tee) and computed tomography imaging showed thrombus.On (b)(6) 2025, the valve got explanted and a new non-abbott valve was implanted.The patient was reported stable and doing well.

• 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: 23441564
• Report Number: 2135147-2025-06297
• Device Sequence Number: 4632851
• Product Code: LWR
• UDI-Device Identifier: 05415067033086
• UDI-Public: (01)05415067033086(17)280617
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 10414541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown