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	Fatigue (1849); Hemorrhage/Blood Loss/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Pericardial Effusion (3271)
Date of Event	03/18/2025
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).It was reported that on (b)(6) 2025, a 31mm epic plus mitral valve was successfully implanted a patient.No difficulty was encountered during the implantation of the 31 mm epic plus mitral valve.In the first few hours post-surgery, the patient experienced hypertension with systolic blood pressure peaks of 180¿220 mmhg, leading to elevated mediastinal drainage output (1,100 ml in 7 hours).Surgical revision was performed, revealing diffuse bleeding from the sternal area, likely due to the hypertensive emergency, but no active bleeding at cardiac sutures.A moderate 18mm pericardial effusion was also noted to have developed, which improved after medication adjustment.Due to the severity of bleeding, heparin was not administered, and activated clotting time (act) levels were not available.At the time of re-operation, the international normalized ratio (inr) was 1.25, and at discharge, it was 1.22.One pool of platelets was transfused in the intensive care unit (icu) before reintervention, with no further transfusions required.There is no allegation of malfunction against the abbott device or procedure.The patient was discharged on the 13th postoperative day and is currently in good clinical condition, although experiencing asthenia due to poor blood pressure control, with a tendency toward hypotension.Antihypertensive medications are being optimized.
Additional Manufacturer Narrative
An event pericardial effusion and bleeding 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 could not be conclusively determined.It is possible procedural conditions contributed to the reported event; however, this cannot be confirmed.The reported interventions were result of case-specific circumstances.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 22749322
• Report Number: 2135147-2025-04392
• Device Sequence Number: 15793729
• Product Code: LWR
• UDI-Device Identifier: 05415067033093
• UDI-Public: (01)05415067033093(17)280617
• 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): 08/29/2025

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: BR00046610
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2024
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 90 KG