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

Model Number	E200-25M
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Codes	Mitral Valve Stenosis (1965); Heart Block (4444)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
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 25mm epic plus mitral valve was implanted in the patient.Post procedure, a complete atrioventricular block (av block) was noted and a pacemaker was attempted.But severe stenosis of superior vena cava was identified.On (b)(6) 2025, the enlargement of the stenotic are with a non-abbott pericardial patch was performed.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of complete atrioventricular block 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 complete atrioventricular block could not be conclusively determined.The reported surgical intervention was a result of case-specific circumstances as the stenosis of the superior vena cava was corrected and a permanent pacemaker was implanted.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 id: (b)(6) (r958586101).It was reported that on (b)(6) 2025, a 25mm epic plus mitral valve was implanted in the patient.Post procedure, a complete atrioventricular block (av block) was noted and a pacemaker was attempted.But severe stenosis of superior vena cava was identified.On (b)(6) 2025, the enlargement of the stenotic are with a non-abbott pericardial patch was performed.

• 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: 23760628
• Report Number: 2135147-2025-07256
• Device Sequence Number: 18674917
• Product Code: LWR
• UDI-Device Identifier: 05415067033048
• UDI-Public: (01)05415067033048(17)270809
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

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: E200-25M
• Device Catalogue Number: E200-25M
• Device Lot Number: BR00041084
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2023
• 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; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 62 KG