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

Model Number	E100-31M-00
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Insufficiency/ Regurgitation (4450); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on an unknown date a 31mm epic valve was selected for implant.After implantation it was thought that a large central jet was seen after the patient was coming off the pump.The valve was replaced with an unknown device.Patient status is unknown.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.
Additional Manufacturer Narrative
An event of a large central jet being seen after the patient was coming off the pump was reported.The device was returned to abbott for investigation.The investigation found that the sewing cuff was intact and all three stent posts were normal in appearance.All three cusps were flexible and contained no tears, perforations or anomalies.Leaflet function was considered normal with all leaflets opening while having no asynchronous motion or leaflet malfunction.No anomalies were found with the valve leaflet, and functional testing at the time of manufacturing and upon return to abbott indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6 health effect - clinical code: code 4450 removed, h6 medical device problem code: code 4068 removed.

• Brand Name: EPIC¿ VALVE (MITRAL)
• 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 #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16896622
• Report Number: 2135147-2023-01999
• Device Sequence Number: 6162836
• Product Code: LWR
• UDI-Device Identifier: 05414734055604
• UDI-Public: 05414734055604
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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 Expiration Date: 03/08/2025
• Device Model Number: E100-31M-00
• Device Catalogue Number: E100-31M-00
• Device Lot Number: 7904255
• 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: 04/14/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2021
• 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