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	Atrial Fibrillation (1729); Bradycardia (1751); Cardiac Arrest (1762); Unspecified Infection (1930); Tachycardia (2095); Heart Failure/Congestive Heart Failure (4446)
Date of Event	08/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Crd_1032 - sh device registry, patient site id: (b)(6).It was reported that on (b)(6) 2026, a 31mm epic plus mitral valve was chosen for implant.Post-procedure on (b)(6) 2026, patient experienced atrial fibrillation as well as repeated bradycardic episodes with asymptomatic pauses on 13 august 2026.Atrial fibrillation transitioned to a brief episode of asystole on 15 august 2026.There was also a pause on bradycardia followed by tachycardic conduction.Patient symptoms were consistent with sick sinus syndrome.Patient was administered medication and underwent two sessions of electrical cardioversions with no result.No further significant pauses occurred until discharge.On 19 august 2026, patient had an ejection fraction of 35% and subsequently received a life vest for three months.It was also reported patient experienced a urinary tract infection on (b)(6) 2026 and was treated with antibiotics same day.
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.

• 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 ; +1(651)756-5400
• MDR Report Key: 50897780
• Report Number: 2135147-2026-06504
• Device Sequence Number: 12225578
• Product Code: LWR
• UDI-Device Identifier: 05415067033093
• UDI-Public: (01)05415067033093(17)290715
• 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: 2026
• 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
• Report Date (Section B): 09/25/2026

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: E200-31M
• Device Catalogue Number: E200-31M
• Device Lot Number: BR00053800
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2025
• 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; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 127 LB