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

Model Number	ESP200-23
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that on 17 nov 2025, a 23mm epic plus supra valve was chosen for a procedure.During procedure, after implant it was noted that the leaflets where not closing properly upon testing with a leaflet tester.The valve got explanted and a new 21mm non-abbott valve was chosen and completed the procedure.
Additional Manufacturer Narrative
An event of incomplete coaptation was reported.The device was returned to abbott for investigation; valve was visually and microscopically examined.The sewing cuff was intact and no anomalies were noted.All three stent posts were normal in appearance.All three leaflets were flexible and contained no tears, perforations or anomalies.The device history record was reviewed to confirm that all manufacturing and inspection steps were completed and that the product met all specifications, including functional testing requirements.The cause of the reported event could not be conclusively determined.The free state of the leaflets, without physiological pressure applied, is not indicative of actual leaflet coaptation or valve function.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on 17 nov 2025, a 23mm epic plus supra valve was chosen for a procedure.During procedure, after implant it was noted that the leaflets where not closing properly upon testing with a leaflet tester.The valve got explanted and a new 21mm non-abbott valve was chosen and completed the procedure while patient on bypass.There was no delay in the procedure.The patient was reported stable and discharged.

• 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: 23790165
• Report Number: 2135147-2025-07305
• Device Sequence Number: 17522967
• Product Code: LWR
• UDI-Device Identifier: 05415067033130
• UDI-Public: (01)05415067033130(17)290319
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ESP200-23
• Device Catalogue Number: ESP200-23
• Device Lot Number: BR00051622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2025
• 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
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 79 KG