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

Catalog Number	E200-29M
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	01/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a 29mm epic valve was implanted using minimally invasive mitral valve repair or replacement (micsmvr).Post-implantation, mild eccentric regurgitation was observed originating from the commissure of one leaflet, spanning from the 6 o'clock to 10 o'clock direction.In response, the heart was temporarily halted, and additional sutures were applied to address the issue.While mild mitral regurgitation (mr) persisted, the chest was subsequently closed, and the operation was completed.The procedure was extended 20 minutes due to re-pumping.The patient remains in stable condition.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
On (b)(6) 2025, a 29mm epic valve was implanted using minimally invasive mitral valve repair or replacement (micsmvr).Post-implantation, mild eccentric regurgitation was observed originating from the commissure of one leaflet, spanning from the 6 o'clock to 10 o'clock direction.In response, the heart was temporarily halted, and additional sutures were applied to address the issue.While mild mitral regurgitation (mr) persisted, the chest was subsequently closed, and the operation was completed.The procedure was extended 20 minutes due to re-pumping.The patient remains in stable condition.
Additional Manufacturer Narrative
An event of mild central mitral valve regurgitation was reported.A more comprehensive assessment, including histopathological examination of the valve tissue, to see if there were any valve abnormalities could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications, including functional testing prior to release form abbott.This test ensures proper cuspal coaptation and hemodynamic performance.Based on the information associated with this complaint, the exact cause of the reported event could not conclusively be determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.The reported hospitalization and surgical intervention was under case-specific circumstances where additional sutures were applied.

• 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 ; 6517565400
• MDR Report Key: 21423024
• Report Number: 2135147-2025-00866
• Device Sequence Number: 7641954
• Product Code: LWR
• UDI-Device Identifier: 05415067033086
• UDI-Public: (01)05415067033086(17)271004(10)BR00043132
• 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
• 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): 03/19/2025

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 Catalogue Number: E200-29M
• Device Lot Number: BR00043132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2023
• 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