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	Dyspnea (1816); Movement Disorder (4412)
Date of Event	04/08/2026
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 08 apr 26, a 29mm epic plus mitral valve was implanted in the patient.After the implant, the patient presented with dyspnea.A chest x-ray showed elevation of the right hemidiaphragm consistent with right hemidiaphragmatic paresis ( secondary to injury of the right phrenic nerve during sternal re-opening).A non invasive mechanical ventilation (nimv) was initiated with a good response.
Event or Problem Description
Clinical information: (b)(6)- sh device registry, patient site id: site id- (b)(6).It was reported that on (b)(6) 2026, a 29mm epic plus mitral valve was implanted in the patient.After the implant, the patient presented with dyspnea.A chest x-ray showed elevation of the right hemidiaphragm consistent with right hemidiaphragmatic paresis ( secondary to injury of the right phrenic nerve during sternal re-opening).A non invasive mechanical ventilation (nimv) was initiated with a good response.The patient was discharged on postoperative day +15 in very good clinical condition.
Additional Manufacturer Narrative
An event for patient effects of dyspnea, movement disorder 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 defined manufacturing specifications.Based on the available information, the cause of the reported patient effects could not be conclusively determined.It is possible that procedural conditions contributed to the reported incidents; however, this cannot be confirmed.The reported unexpected medical interventions was a 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 ; +1(651)756-5400
• MDR Report Key: 25255388
• Report Number: 2135147-2026-03490
• Device Sequence Number: 16080095
• Product Code: LWR
• UDI-Device Identifier: 05415067033086
• UDI-Public: (01)05415067033086(17)291027
• 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: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2026

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: BR00055639
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Supplement Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2025
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 264 LB