MAUDE Adverse Event Report: ABBOTT MEDICAL REGENT HEART VALVE WITH FLEX CUFF; HEART-VALVE, MECHANICAL

Model Number	19AGFN-756
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not returning for evaluation.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) 2025, a 19mm regent aortic mechanical heart valve was selected for implant.During device preparation, the leaflets were moving normally when tested.Silicone products were used to test leaflet function.After implant, esophageal ultrasound showed that the valve could not open and close normally.The valve was explanted and upon explant, leaflet function was tested again and they were moving normally, "but it's a little difficult." the valve was exchanged for a new 17mm regent aortic mechanical heart valve, which was successfully implanted.Esophageal ultrasound was repeated and the valve was opening and closing normally.The patient was reported to in good condition.
Additional Manufacturer Narrative
It was reported that the valve was not opening and closing normally post implant.The device was returned to abbott for investigation.No anomalies were found with the valve leaflets with both leaflets able to fully open and close without resistance.Hydrodynamic examination indicated the valve met functional specification.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.A smaller valve was successfully implanted, so it is possible the valve was miss-sized, which could have contributed to the reported event.The exact cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: REGENT HEART VALVE WITH FLEX CUFF
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2648612; lot 20 b st caguas; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21577155
• Report Number: 2135147-2025-01232
• Device Sequence Number: 8647283
• Product Code: LWQ
• UDI-Device Identifier: 05415067042934
• UDI-Public: (01)05415067042934(17)281001
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P810002
• 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): 04/21/2025

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: 19AGFN-756
• Device Catalogue Number: 19AGFN-756
• Device Lot Number: C00015885
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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 Sex: Unknown