MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC PLUS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	E200-33M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Pleural Effusion (2010); Tachycardia (2095); Pericardial Effusion (3271); Heart Block (4444); Heart Failure/Congestive Heart Failure (4446)
Date of Event	12/18/2025
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) (r973411601).It was reported that on (b)(6) 2025, a 33mm epic plus mitral valve was chosen for a procedure.After the procedure, the patient experienced various fluctuating cardiac arrhythmias.The patient was under continues monitoring.The patient's rhythm was changing from atrial fibrillation, atrioventricular (av) nodal reentrant tachycardia and av block-1.Some medications were given.Post procedure, the patient had a bronchopulmonary infection and rising inflammation levels.The patient treated with antibiotics.The patient had pleural effusion with punction and medications were given.The patient had a significantly impaired left ventricular function.On (b)(6) 2025, the patient had a pericardial effusion and medications given.On (b)(6) 2026, the patient had sinus rhythm with av block and medications given.A cardioversion was performed on (b)(6) 2025.On (b)(6) 2025, the transthoracic echocardiography (toe) noted the patient having ejection fraction (ef) 40 %, on (b)(6) 2025, ef 25 %, on (b)(6) 2026 ~ ef 35 % and medications were given.
Additional Manufacturer Narrative
An event involving heart failure, heart block, atrial fibrillation, and pericardial effusion 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 specifications.Based on the available information, the cause of the reported atrial fibrillation cannot be definitively established.The noted heart block may be secondary to the identified atrial fibrillation.Likewise, the underlying causes of the pericardial effusion and heart failure cannot be conclusively determined from the current data.It is possible procedural condition or pre-existing patient condition contributed to the reported event; however, this could not be confirmed.The reported unexpected medical intervention was results of case-specific circumstances as the patient was given medication.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
Clinical information: (b)(4) - sh device registry, patient site id: (b)(6).It was reported that on (b)(6) 2025, a 33mm epic plus mitral valve was chosen for a procedure.After the procedure, the patient experienced various fluctuating cardiac arrhythmias.The patient was under continues monitoring.The patient's rhythm was changing from atrial fibrillation, atrioventricular (av) nodal reentrant tachycardia and av block-1.Some medications were given.Post procedure, the patient had a bronchopulmonary infection and rising inflammation levels.The patient treated with antibiotics.The patient had pleural effusion with punction and medications were given.The patient had a significantly impaired left ventricular function.On (b)(6) 2025, the patient had a pericardial effusion and medications given.On (b)(6) 2026, the patient had sinus rhythm with av block and medications given.A cardioversion was performed on (b)(6) 2025.On (b)(6) 2025, the transthoracic echocardiography (toe) noted the patient having ejection fraction (ef) 40 %, on (b)(6) 2025, ef 25 %, on (b)(6) 2026 ~ ef 35 % and medications were given.The patient was reported stable and was in rehabilitation after discharge.

• Brand Name: EPIC PLUS
• 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: 24298296
• Report Number: 2135147-2026-00740
• Device Sequence Number: 15785993
• Product Code: LWR
• UDI-Device Identifier: 05415067033109
• UDI-Public: (01)05415067033109(17)290709
• 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: 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): 04/02/2026

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: E200-33M
• Device Catalogue Number: E200-33M
• Device Lot Number: BR00053359
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2025
• 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; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 62 KG