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

Catalog Number	E200-31M
Medical Device Problem Codes	Incomplete Coaptation (2507); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	10/30/2024
Type of Reportable Event	Serious Injury
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) 2024, a 31m epic mitral valve (serial: (b)(6)) was chosen for implantation.Pre procedure mitral regurgitation was grade 3+.After implant and immediately after reversing cardioplegia, a small leaflet prolapse was observed resulting in mitral regurgitation grade 1+.No intervention was performed and patient was discharged.
Additional Manufacturer Narrative
An event of mitral regurgitation was immediately after implant and small leaflet prolapse was reported.A returned device assessment 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 inspection for proper coaptation.Provided images appeared to show a large regurgitant jet across the mitral valve seen on multiple views consistent with severe mitral valve regurgitation before implant.Short axis native aortic valve view shows tri-leaflet aortic valve with good coaptation.Small transvalvular regurgitant jet seen following mitral valve replacement.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 20796846
• Report Number: 2135147-2024-06048
• Device Sequence Number: 6895115
• Product Code: LWR
• UDI-Device Identifier: 05415067033093
• UDI-Public: (01)05415067033093(17)280325(10)BR00044195
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 02/25/2025

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: E200-31M
• Device Lot Number: BR00044195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2024
• 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: Other
• Patient Sex: Unknown