MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC¿ SUPRA VALVE (AORTIC); HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	ESP200-21
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Angina (1710); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	08/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, the patient underwent aortic valve replacement (avr) procedure with a 21mm epic plus supra valve and coronary artery bypass graft surgery (cabg).The annular diameter of the native valve was 21mm.Immediate post-operative, the patient had exertional angina and transesophageal echocardiogram (tee) showed mild aortic regurgitation (ar).On (b)(6) 2025, tte demonstrated progression to moderate ar.Subsequent tte performed on (b)(6) 2025 confirmed moderately severe ar (3+) with stable hemodynamics.There was no intervention performed for mid aortic regurgitation (ar).The patient was reported stable and discharged.
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.
Additional Manufacturer Narrative
An event of central regurgitation and aortic valve regurgitation was reported.A returned device inspection 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.The investigation was unable to determine the cause of the reported central regurgitation, aortic valve regurgitation, and angina.The reported serious injury/illness/impairment was a result of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
N/a.

• Brand Name: EPIC¿ SUPRA VALVE (AORTIC)
• 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: 23184128
• Report Number: 2135147-2025-05531
• Device Sequence Number: 21330105
• Product Code: LWR
• UDI-Device Identifier: 05415067033123
• UDI-Public: (01)05415067033123(17)290401
• 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: 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): 12/30/2025

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: ESP200-21
• Device Catalogue Number: ESP200-21
• Device Lot Number: BR00051848
• 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: 09/05/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2025
• 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: Other
• Patient Age: 68 YR
• Patient Sex: Male