MAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS SERIES HEART VALVE WITH TEFLON CUFF; HEART-VALVE, MECHANICAL

Model Number	23MTJ-503
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	07/25/2025
Type of Reportable Event	Serious Injury
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 (b)(6) 2022, a 23mm masters series heart valve with expanded teflon was implanted.The leaflets were functioning normally until early (b)(6) 2025.On (b)(6) 2025, there was "concern that the valve may have become stuck." echocardiography was performed which showed stuck leaflets.Thrombus had accumulated at the pivot and the valve was explanted.Upon explant, leaflet function was tested and "were stuck due to material adhered to the pivot." a new 25mm non-abbott device was implanted.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
An event of leaflet incomplete coaptation and thrombus found upon explant of the device was reported.The device was returned to abbott for investigation and found torn cuff.Both leaflet were intact and able to open and close freely.The valve was unable to be rotated freely.Hydrodynamic testing 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, including functional testing at the time of manufacturing, and the product met all specifications.The cause of the reported incomplete coaptation could not be conclusively determined.No thrombus was found upon device return.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: MASTERS SERIES HEART VALVE WITH TEFLON 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: 22833926
• Report Number: 2135147-2025-04625
• Device Sequence Number: 9567043
• Product Code: LWQ
• UDI-Device Identifier: 05414734053600
• UDI-Public: (01)05414734053600(17)270120
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 10/21/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 23MTJ-503
• Device Catalogue Number: 23MTJ-503
• Device Lot Number: 8305048
• 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: 07/25/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2022
• 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 Age: 62 YR
• Patient Sex: Male