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	Hemorrhage/Blood Loss/Bleeding (1888); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	11/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event for patient effects of pericardial effusion, cardiac tamponade, bleeding 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 reported pericardial effusion led to cardiac tamponade and bleeding were related to the procedural conditions (complex cardiac surgery, impaired wound healing, postoperative bleeding, device implant).The reported hospitalization and unexpected medical interventions were the results of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
Linical information: crd_1032 - 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.There was no difficulty implanting the valve, such as multiple manipulations.During procedure the patient had a minimum activated clotting time (act) level of 164 seconds and maximum act of over 1000 seconds.The patient was also administered 450mg of protaminsulfate during procedure.The patient was not taking any anticoagulant or antiplatelet medication prior to procedure.On (b)(6) 2024, an echocardiogram was performed and revealed a lateral right ventricular pericardial effusion.The patient was taking 100mg of acetylsalicylic acid and low molecular weight heparin at the time the pericardial effusion was noted.The patient was administered antiphlogistic.There was no pericardial effusion noted prior to procedure.On (b)(6) 2024, the pericardial effusion was noted to have grown with the largest dimension of the effusion being 24mm.The patient also developed cardiac tamponade.The decision was made to perform a pericardial punction for drainage of the pericardial effusion.The cause of the patient's pericardial effusion is attributed to the implant procedure, impaired wound healing, and post-operative bleeding.There is no allegation of malfunction against the abbott device or procedure.The patient was recovered 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.
Event or Problem Description
Clinical information: crd_1032 - sh device registry, patient site id: (b)(6) , (b)(4).It was reported that on (b)(6) 2024, a 25mm epic max valve was successfully implanted in a patient.There was no difficulty implanting the valve, such as multiple manipulations.During procedure the patient had a minimum activated clotting time (act) level of 164 seconds and maximum act of over 1000 seconds.The patient was also administered 450mg of protaminsulfate during procedure.The patient was not taking any anticoagulant or antiplatelet medication prior to procedure.On (b)(6) 2024, an echocardiogram was performed and revealed a lateral right ventricular pericardial effusion.The patient was taking 100mg of acetylsalicylic acid and low molecular weight heparin at the time the pericardial effusion was noted.The patient was administered antiphlogistic.There was no pericardial effusion noted prior to procedure.On (b)(6) 2024, the pericardial effusion was noted to have grown with the largest dimension of the effusion being 24mm.The patient also developed cardiac tamponade.The decision was made to perform a pericardial punction for drainage of the pericardial effusion.The cause of the patient's pericardial effusion is attributed to the implant procedure, impaired wound healing, and post-operative bleeding.There is no allegation of malfunction against the abbott device or procedure.

• 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: 21003881
• Report Number: 2135147-2024-06551
• Device Sequence Number: 12465010
• Product Code: LWR
• UDI-Device Identifier: 05415067045454
• UDI-Public: (01)05415067045454(17)280214(10)BR00043042
• 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): 02/02/2025

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: BR00043042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 12/23/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 99 KG