MAUDE Adverse Event Report: Abbott Medical Epic¿ Supra Valve (Aortic); Heart-Valve, Non-Allograft Tissue

Model Number	ESP200-19
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Obstruction/Occlusion (2422)
Date of Event	06/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 19mm epic plus supra valve was chosen for a procedure.The valve was implanted as per the standard surgical protocol.Following weaning from cardiopulmonary bypass (cpb), intraoperative transesophageal echocardiogram tee demonstrated persistently high transvalvular gradients across the prosthesis (ppg/mpg: 70/46 mmhg).After a thorough evaluation, no technical, anatomical, or surgical cause, including left ventricular outflow tract obstruction (lvoto), was identified.The patient was placed back on cpb, the valve was explanted, and a non-abbott mechanical valve was implanted.Repeat tee showed satisfactory valve function with acceptable gradients (ppg/mpg: 30/17 mmhg).The patient was subsequently weaned off cpb successfully, and the remainder of the procedure was uneventful.The patient was shifted to the intensive care unit (icu) with stable hemodynamics.There was no delay in the procedure.The patient was reported discharged.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

• 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 ; +1(651)756-5400
• MDR Report Key: 50011375
• Report Number: 2135147-2026-05049
• Device Sequence Number: 8385660
• Product Code: LWR
• UDI-Device Identifier: 05415067033116
• UDI-Public: (01)05415067033116(17)300125
• 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
• Report Date (Section B): 07/23/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ESP200-19
• Device Catalogue Number: ESP200-19
• Device Lot Number: BR00056503
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2026
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 182 LB