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

Model Number	E200-27M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	11/10/2025
Type of Reportable Event	Serious Injury
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 27mm epic plus mitral valve and 23mm epic max valve were implanted in the patient.Post operative, the patient had a complete atrioventricular (av) block.On (b)(6) 2025, a permanent pacemaker was implanted.
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) - sh device registry, patient site id: e(b)(6).It was reported that on (b)(6) 2025, a 27mm epic plus mitral valve and 23mm epic max valve were implanted in the patient.Post operative, the patient had a complete atrioventricular (av) block.On (b)(6) 2025, a permanent pacemaker was implanted.
Additional Manufacturer Narrative
An event of complete heart block 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 information received, the cause of the complete heart block could not be conclusively determined.It is possible procedural condition or pre-existing patient condition contributed to the reported event; however, this could not be confirmed.The reported surgical intervention was results of case-specific circumstances as 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: (b)(4) - sh device registry, patient site id: (b)(6).It was reported that on (b)(6) 2025, a 27mm epic plus mitral valve and 23mm epic max valve were implanted in the patient.During post operative hours, patient had a stroke and mediations were given.After implant, the patient had a complete atrioventricular (av) block.On (b)(6) 2025, a permanent pacemaker was implanted.
Additional Manufacturer Narrative
An event of complete heart block 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 information received, the cause of the complete heart block could not be conclusively determined.It is possible procedural condition or pre-existing patient condition contributed to the reported event; however, this could not be confirmed.The reported surgical intervention was results of case-specific circumstances as a permanent pacemaker was implanted.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: 24332077
• Report Number: 2135147-2026-00857
• Device Sequence Number: 5018815
• Product Code: LWR
• 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,Followup
• Report Date (Section B): 06/30/2026

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: E200-27M
• Device Catalogue Number: E200-27M
• Device Lot Number: BR00050879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 02/27/2026; 06/22/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/06/2026; 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2025
• 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: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 165 LB