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

Model Number	E200-25M
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	01/08/2026
Type of Reportable Event	Death
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) 2026, a 25mm epic plus mitral valve was chosen for a procedure.The valve was implanted.Two hours after the procedure, it was noted that the leaflets did not work properly and loss of patient life.The cause of death was cardiac arrest.The physician mentioned the cause of death was implanted device.
Event or Problem Description
It was reported that on (b)(6) 2026, a 25mm epic plus mitral valve was chosen for a procedure.The valve was implanted.Two hours after the procedure, there was a difficulty with valve leaflets opening and closing was noted and patient had lost life.The cause of death was cardiac arrest.The physician mentioned the cause of death was implanted device.
Additional Manufacturer Narrative
An event of leaflets not being coapting after implant, cardiac arrest and patient death was reported.A returned device assessment could not be performed as the device 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.This includes functional testing of the device which ensures proper cuspal coaptation and hemodynamic performance.Based on the information received, the cause of the reported event could not be conclusively determined.Per the information available abbott cannot further speculate on why the reported event occurred.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Based on medical review: it is less likely for the decreased leaflet motion to be related to thrombus formation particularly within 2 hours post-implant.It is also unlikely that the leaflet was not moving due to suturing since this would have been noticed much earlier.The exact cause of death remains unknown, but most likely is procedure related.

• 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: 24241014
• Report Number: 2135147-2026-00586
• Device Sequence Number: 8970825
• Product Code: LWR
• UDI-Device Identifier: 05415067033048
• UDI-Public: (01)05415067033048(17)290622
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: E200-25M
• Device Catalogue Number: E200-25M
• Device Lot Number: BR00053030
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2025
• 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: Death; Disability
• Patient Sex: Unknown