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

Model Number	EMAX-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Transient Ischemic Attack (2109); Cardiac Tamponade (2226)
Date of Event	09/23/2025
Type of Reportable Event	Serious Injury
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
Clinical information: (b)(6) - sh device registry, patient site id: (b)(6).It was reported that on (b)(6) 2025, a 25mm epic max valve was implanted in the patient.Immediate post operative period, showed significant bleeding (1,500ml in the first 4hrs).A surgical intervention was performed to diffuse active bleeding throughout the cardiac dissection and a mediastinal packing was done.A cardiac tamponade was noted after leaving a mediastinal packing.The mediastinal packing was removed.After the implant, a right cerebral stroke was established in the patient.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event for patient effects of hemorrhage, transient ischemic attack, and cardiac tamponade 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 defined manufacturing specifications.Based on the information received, a cause for the reported hemorrhage, transient ischemic attack, and cardiac tamponade could not be determined.The reported surgical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: EPIC MAX 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: 23575509
• Report Number: 2135147-2025-06708
• Device Sequence Number: 9398524
• Product Code: LWR
• UDI-Device Identifier: 05415067045454
• UDI-Public: (01)05415067045454(17)271128
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: EMAX-25
• Device Catalogue Number: EMAX-25
• Device Lot Number: BR00041882
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2023
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 90 KG