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 Codes	Pleural Effusion (2010); Pericardial Effusion (3271)
Date of Event	09/16/2024
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
Clinical information: (b)(6) - sh device registry, patient site id: (b)(6).It was reported that on (b)(6) 2024, a 25mm epic max valve was successfully implanted in a patient.On (b)(6) 2024, it was noted that the patient developed a pericardial effusion and a pleural effusion.The decision was made to perform a pericardial drainage and pleural puncture.The patient was in stable condition at the time of report.
Additional Manufacturer Narrative
An event for pericardial effusion and a pleural effusion 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 defined manufacturing specifications.Based on the information received, the cause for the reported pericardial effusion and pleural effusion is attributed to the implant procedure.There is no allegation of malfunction against the abbott device or procedure.The reported unexpected medical interventions was a resulted of case-specific circumstances, as medication was given.
Event or Problem Description
Subsequent to the previously filed report, additional information was received that the patient had been administered 45,000 ie of heparin and had an activated clotting time level of 728 seconds at the end of procedure.There was no difficulty implanting the 25mm epic max valve.The patient did not have a pericardial effusion prior to procedure.The pericardial effusion was circular, 12mm lateral to the right ventricle/atrium, and 14mm lateral to the left ventricle.The largest dimension of the pericardial effusion was 17mm.There was no cardiac tamponade present.The patient was taking acetylsalicylic acid and certoparin at the time the pericardial effusion was discovered.The cause of the patient's pericardial effusion and pleural effusion is attributed to the implant procedure.There is no allegation of malfunction against the abbott device or procedure.The patient was discharged to rehabilitation at the time of report.

• 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: 21547869
• Report Number: 2135147-2025-01163
• Device Sequence Number: 8050154
• Product Code: LWR
• UDI-Device Identifier: 05415067045454
• UDI-Public: (01)05415067045454(17)280128(10)BR00042796
• 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): 04/03/2025

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: BR00042796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2024
• 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; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 72 KG