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

Model Number	E200-33M
Medical Device Problem Codes	Product Quality Problem (1506); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	05/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 33mm epic plus mitral valve was implanted.Following the implant, the patient experienced severe mi.The physician discovered that one of the leaflets was larger/longer than the other two.The physician was able to fix the issue with a 6.0 suture.They don't believe the patient or user experienced adverse health consequences due to the performance of the product.The patient remained hemodynamically stable throughout the procedure and no clinically significant delay reported.The patient is stable.
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of one leaflet appeared larger/longer than the other two and central regurgitation was reported.A returned device inspection, to rule out any device-related causes, 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, including functional testing to ensure proper leaflet coaptation and hemodynamic performance, and the product met all specifications.Based on the available information, the cause of the reported event could not be conclusively determined.The reported surgical intervention was a result of case-specific circumstances as the reported issue was resolved with a 6.0 suture.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: 22206149
• Report Number: 2135147-2025-03215
• Device Sequence Number: 7714661
• Product Code: LWR
• UDI-Device Identifier: 05415067033109
• UDI-Public: (01)05415067033109(17)280805
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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: E200-33M
• Device Catalogue Number: E200-33M
• Device Lot Number: BR00047485
• 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: 05/19/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2024
• 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
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 68 KG