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 Code	Aortic Valve Stenosis (1717)
Date of Event	12/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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) 2024, a 19mm epic plus supra valve was selected for implant.During procedure, the epic valve was seated well.However, post-implant, the valve appeared too tight and caused high gradients.The valve was explanted and a new 17mm masters series hemodynamic plus valve was successfully implanted.There are no allegation of malfunction with the 19mm epic valve.The user alleged that the cause of the high gradients was that the 19mm epic was too small.High gradient did not persist after the 19mm epic was explanted.The patient was reported to have been discharged.
Additional Manufacturer Narrative
An event for device stenosis and aortic valve stenosis 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.Additionally, a review of the complaint history identified no other complaints reported from this lot.Based on the information received, a cause for the reported device stenosis and aortic valve stenosis could not be conclusively determined.The reported unexpected medical interventions were a result of case-specific circumstances, as the device was surgical removed.
Additional Manufacturer Narrative
An event for device stenosis was reported and was not confirmed through analysis of the returned device.Analysis of the returned device found the sewing cuff to be intact, with no anomalies observed on the leaflets.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Additionally, a review of the complaint history identified no other complaints reported from this lot.The investigation was unable to determine the cause of the reported device stenosis and aortic valve stenosis.The reported unexpected medical interventions were a result of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Codes removed: component code: 4755 part/component/sub-assembly term not applicable.Type of investigation: 4114 device not returned.Investigation findings: 3221 no findings available.Investigation conclusions: 4315 cause not established.

• 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: 21038289
• Report Number: 2135147-2024-06681
• Device Sequence Number: 12896435
• Product Code: LWR
• UDI-Device Identifier: 05415067033116
• UDI-Public: (01)05415067033116(17)280313
• 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: 2024
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 07/17/2025

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: BR00043617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 02/27/2025; 07/12/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 03/07/2025; 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• 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: Other; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 65 KG