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

Model Number	E200-27M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Pleural Effusion (2010); Electrolyte Imbalance (2196); Movement Disorder (4412); Respiratory Insufficiency (4462)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains 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)(4) - sh device registry, patient site (b)(6).It was reported that on (b)(6) 2025, a 27mm epic plus mitral valve was implanted in the patient.After the procedure, the patient observed anemia and hypokalemia and potassium supplements were given on (b)(6) 2025.Due to pleural effusion and respiratory failure, a thoracentesis was performed.The patient developed a delirium and was treated with medication.
Additional Manufacturer Narrative
An event of pericardial effusion, and anemia 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 specifications.Based on the available information, the cause of the reported pericardial effusion, and anemia could not be conclusively determined.It is possible that procedural conditions contributed to the reported incidents; however, this cannot be confirmed.The reported unexpected medical intervention was due to case-specific circumstances, as medication was provided.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: crd_1032 - sh device registry, patient site (b)(6).It was reported that on (b)(6) 2025, a 27mm epic plus mitral valve was implanted in the patient.After the procedure, the patient observed anemia.Four days of the procedure, the patient had hypokalemia.Some potassium supplements were given on (b)(6) 2025.Due to pleural effusion and respiratory failure a thoracentesis was performed.The patient developed a delirium and was treated with medication.The patient was reported discharged.

• 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: 24548563
• Report Number: 2135147-2026-01483
• Device Sequence Number: 9377575
• Product Code: LWR
• UDI-Device Identifier: 05415067033062
• UDI-Public: (01)05415067033062(17)281007
• 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): 04/22/2026

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: E200-27M
• Device Catalogue Number: E200-27M
• Device Lot Number: BR00049241
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2024
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 60 KG