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

Model Number	E200-29M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Flutter (1730); Stroke/CVA (1770); Pleural Effusion (2010); Cardiac Tamponade (2226); Pericardial Effusion (3271); Movement Disorder (4412)
Date of Event	11/21/2025
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)(4), patient site id: (b)(6).It was reported that on (b)(6) 2025, a 29mm epic plus mitral valve was implanted in the patient.After the procedure, the patient exhibited left sided hemiparesis during the recovery phase.The computerized tomography (ct) scan unremarkable but a stroke was diagnosed during a neurological consultation.The patient required 26 days of hospitalization, physiotherapy and neurological rehabilitation were given to patient.The hemiparesis of the left arm and leg was still present at the discharge.On (b)(6) 2025, a pericardial effusion was detected during ultrasound and a pericardiocentesis was performed.There was beginning signs of tamponade.The physician mentioned abbott device caused the pericardial effusion.After that atrial flutter was noted and a cardioversion was performed.The patient had a pleural effusion and diuretics was given to the patient.On (b)(6) 2025, some medications were administrated to the patient.The patient was reported in the recovery phase.
Additional Manufacturer Narrative
An event of pericardial effusion, cardiac tamponade, atrial flutter and stroke 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 pericardial effusion, cardiac tamponade, atrial flutter and stroke could not be conclusively determined.It is possible that procedural conditions contributed to the reported incidents; however, this cannot be confirmed.The reported hospitalization and unexpected medical intervention were due to case-specific circumstances, as the patient was hospitalized, and underwent pericardiocentesis.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 29mm epic plus mitral valve was implanted in the patient.After the procedure, the patient exhibited left sided hemiparesis during the recovery phase.The computerized tomography (ct) scan unremarkable but a stroke was diagnosed during a neurological consultation.The patient required 26 days of hospitalization, physiotherapy and neurological rehabilitation were given to patient.The hemiparesis of the left arm and leg was still present at the discharge.On (b)(6) 2025, a pericardial effusion was detected during ultrasound and a pericardiocentesis was performed.There was beginning signs of tamponade.The physician mentioned abbott device caused the pericardial effusion.After that atrial flutter was noted and a cardioversion was performed.The patient had a pleural effusion and diuretics was given to the patient.On (b)(6) 2025, some medications were administrated to the patient.The patient was reported in the recovery phase.

• 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: 24277788
• Report Number: 2135147-2026-00676
• Device Sequence Number: 8365478
• Product Code: LWR
• UDI-Device Identifier: 05415067033086
• UDI-Public: (01)05415067033086(17)290223
• 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): 03/18/2026

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: E200-29M
• Device Catalogue Number: E200-29M
• Device Lot Number: BR00051179
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2025
• 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: Disability; Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 75 KG