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

Model Number	E200-31M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Shock (2072); Heart Failure/Congestive Heart Failure (4446)
Date of Event	06/11/2025
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: crd_1032 - sh device registry, patient site id: (b)(6).It was reported that on 11 june 2025, a 31mm epic plus mitral valve was successfully implanted in a patient.Post-procedure, it was noted that the patient developed cardiogenic shock that required the patient be placed on extracorporeal membrane oxygenation (ecmo).After a positive outcome the patient was able to wean off ecmo after 7 days.There were no further incidents noted.No additional information was provided.
Additional Manufacturer Narrative
An event of cardiogenic shock and right ventricular dysfunction 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 incident could not be conclusively determined.The reported hospitalization and unexpected medical intervention were results of case specific circumstances as the patient was hospitalized and placed on ecmo and medication was administered.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: health effect- impact code: 4624 surgical intervention.
Event or Problem Description
Clinical information: crd_1032 - sh device registry, patient site id: (b)(6).It was reported that on (b)(6) 2025, a 31mm epic plus mitral valve was successfully implanted in a patient.Post-procedure, it was noted that the patient developed cardiogenic shock that required the patient be placed on extracorporeal membrane oxygenation (ecmo).After a positive outcome the patient was able to wean off ecmo after 7 days.The patient presented with right ventricular dysfunction on being weaned from ecmo.That led to re-entry for a few minutes and optimization of drug therapy.Furthermore, in the operating room, the patient required a transfusion of blood products and the administration of abundant procoagulant factors due to a significant coagulation disorder.There was the presence of lymphorrhage at the ecmo cannulation site, and conservative management was chosen.The patient is in good clinical condition and reported discharged on the 19th postoperative day.

• 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: 22927035
• Report Number: 2135147-2025-04915
• Device Sequence Number: 15743727
• Product Code: LWR
• UDI-Device Identifier: 05415067033093
• UDI-Public: (01)05415067033093(17)281006
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 12/12/2025

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 Model Number: E200-31M
• Device Catalogue Number: E200-31M
• Device Lot Number: BR00048941
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2024
• 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; Other; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 70 KG