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

Model Number	E200-27M
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Movement Disorder (4412)
Date of Event	06/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explant approximately 1-year post-implant due to pannus ingrowth was reported.The device was returned to abbott for investigation, and a fibrotic thickening of leaflet was observed in one cusp.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.Based on the available information, the cause of the reported pannus formation, fibrous thickening, and folding in the leaflets could not be conclusively determined.It is possible underlying patient condition contributed to the reported event; however, this cannot be confirmed.The reported hospitalization and surgical intervention were results of case-specific circumstances as the patient was admitted explanting the valve.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 on (b)(6) 2025, a 27mm epic plus mitral valve was implanted in the patient.On (b)(6) 2026, a dizziness was observed in the patient prior to resection.A mass-like attachment was found on the valve.The valve got explanted and a new 27mm epic plus mitral valve was implanted.The explanted valve had a slight pannus-like structure was attached to the commissural area.There was no tear was observed in the leaflets and suture cuff.The patient was reported stable and hospitalized.
Additional Manufacturer Narrative
Investigation is not yet complete.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 27mm epic plus mitral valve was implanted in the patient.On (b)(6) 2026, a dizziness was observed in the patient prior to resection.A mass-like attachment was found on the valve.The valve got explanted and a new 27mm epic plus mitral valve was implanted.The explanted valve had a slight pannus-like structure was attached to the commissural area.There was no tear was observed in the leaflets and suture cuff.The patient was reported stable and hospitalized.

• 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: 25803164
• Report Number: 2135147-2026-04819
• Device Sequence Number: 5842215
• Product Code: LWR
• UDI-Device Identifier: 05415067033062
• UDI-Public: (01)05415067033062(17)280519
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: E200-27M
• Device Catalogue Number: E200-27M
• Device Lot Number: BR00045820
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/07/2026
• 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: 06/18/2026
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 07/13/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2024
• 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: 71 YR
• Patient Sex: Male