MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC¿ SUPRA VALVE (AORTIC); HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	ESP200-21
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	03/09/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2026, a 21mm epic plus supra valve was implanted in the patient.After the implant, the outcome was not favorable, gradient was too high.The valve got explanted and a new non-abbott valve was implanted intra-procedurally while the patient remained on cardiopulmonary bypass.After the implant unfortunately the patient didn¿t survive.The exact cause of the death was not specified.
Additional Manufacturer Narrative
An event of heart failure, and patient's death were reported.Information from the field indicated that after the implant, the outcome was not favorable, gradient was too high.The valve got explanted and a new non-abbott valve was implanted intra-procedurally while the patient remained on cardiopulmonary bypass.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 heart failure and patient's death could not be conclusively determined.It is possible that patient underlying pre-existing condition and medical history contributed to the reported event; however, this cannot be confirmed.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Based on medical review: "the exact details of the save procedure are not available including the reason leading to the fatality.It is unknown why the patient had an elevated transvalvular gradient and what kind of replacement valve was used including whether any additional procedures such as an aortic annular enlargement was undertaken.Considering the fatality occurred on the same day of the procedure, the fatality is considered procedure related.A fatality on the same day of a savr may be related to a prolonged cardiopulmonary bypass time and related to a myocardial preservation issue that may result in a stunned myocardium, or related to bleeding, or other complication such as a ventricular arrhythmia and sudden cardiac death.In this case the exact details of the procedure and post-procedure care are unknown such that it is not possible to determine the exact cause of death.An elevated gradient following implantation of the epic supra valve may be related to patient prosthesis mismatch, sub-valvular stenosis, acute valvular thrombosis, technical implant error, and/or other conditions.In this case it is unknown what caused the elevated transvalvular gradient.".
Event or Problem Description
It was reported that on 09 mar 2026, a 21mm epic plus supra valve was implanted in the patient.After the implant, the outcome was not favorable, gradient was too high.The valve got explanted and a new non-abbott valve was implanted intra-procedurally while the patient remained on cardiopulmonary bypass.After the implant unfortunately the patient didn¿t survive.The exact cause of the death was not specified.

• Brand Name: EPIC¿ SUPRA VALVE (AORTIC)
• 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: 24778661
• Report Number: 2135147-2026-02132
• Device Sequence Number: 6134584
• Product Code: LWR
• UDI-Device Identifier: 05415067033123
• UDI-Public: (01)05415067033123(17)280311
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

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: ESP200-21
• Device Catalogue Number: ESP200-21
• Device Lot Number: BR00044001
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 06/13/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2024
• 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: Death
• Patient Sex: Unknown