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

Catalog Number	EMAX-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Renal Failure (2041)
Date of Event	12/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical information: (b)(4).) it was reported that on (b)(6) 2024, 25mm epic max valve was successfully implanted in a patient.There was no difficulty experienced implanting the 25mm epic max valve.On (b)(6) 2024, the patient was found to have post-operative renal insufficiency confirmed via lab testing.The decision was made to administer intravenous diuretics and acetylcysteine.There was no initial or prolonged hospitalization due to this event.There is no allegation of malfunction against the abbott device or procedure.The direct cause of the patient's renal insufficiency is unknown.The patient was in stable condition at the time of report.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event for patient effects of renal failure 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, the cause for the reported renal failure could not be conclusively determined.The reported unexpected medical interventions was a resulted 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 north; 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21386076
• Report Number: 2135147-2025-00749
• Device Sequence Number: 20929750
• Product Code: LWR
• UDI-Device Identifier: 05415067045454
• UDI-Public: (01)05415067045454(17)280319(10)BR00044175
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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 Catalogue Number: EMAX-25
• Device Lot Number: BR00044175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2024
• 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: 84 YR
• Patient Sex: Male
• Patient Weight: 114 KG