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

Model Number	ESP200-19
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Coronary obstruction/occlusion (4871)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of valve explant was reported.Information from the field indicated that the after implant it was observed that the valve was too tight and obstructing the ostia.The device was returned to abbott for investigation which revealed that the sewing cuff was noted to have a small tear.All three stent posts were normal in appearance.There were no perforations or tears observed and the cusps were mobile.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The cause of surgical intervention was case specific where device was explanted.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: component code: 4755 part/component/sub-assembly term not applicable.Type of investigation: 4118 type of investigation not yet determined; investigation findings: investigation conclusions: 11 conclusion not yet available.
Event or Problem Description
It was reported that on (b)(6) 2025, a 19mm epic plus supra valve was chosen for a procedure.The device was sized correctly and implanted.Post implantation, it was observed that the valve was too tight and obstructing the ostia.The surgeon decided to explant the valve.The valve was explanted and a new 17mm non-abbott valve was implanted.The patient was reported stable.
Additional Manufacturer Narrative
Investigation is not yet complete.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 ; 6517565400
• MDR Report Key: 21598979
• Report Number: 2135147-2025-01254
• Device Sequence Number: 8939312
• Product Code: LWR
• UDI-Device Identifier: 05415067033116
• UDI-Public: (01)05415067033116(17)280829
• 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: 2025
• Device Explanted Year: 2025
• 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): 04/17/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: ESP200-19
• Device Catalogue Number: ESP200-19
• Device Lot Number: BR00048169
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2024
• 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: Required Intervention
• Patient Sex: Unknown