MAUDE Adverse Event Report: ABBOTT MEDICAL Masters Series Mechanical Heart Valve; Heart-Valve, Mechanical

Model Number	29MJ-501
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Movement Disorder (4412); Thrombosis/Thrombus (4440); Insufficient Information (4580)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
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 27mm epic plus mitral valve was implanted in the patient.On (b)(6) 2026, a dizziness was observed in the patient prior to resection.A mass-like attachment was found on the valve.The valve got explanted and a new 27mm epic plus mitral valve was implanted.The explanted valve had a slight pannus-like structure was attached to the commissural area.There was no tear was observed in the leaflets and suture cuff.The patient was reported stable and hospitalized.

• Brand Name: Masters Series Mechanical Heart Valve
• 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 ; PR 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 25802999
• Report Number: 2135147-2026-04818
• Device Sequence Number: 15703099
• Product Code: LWQ
• UDI-Device Identifier: 05415067045058
• UDI-Public: (01)05415067045058(17)210705
• 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: 2016
• Device Explanted Year: 2026
• 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): 09/14/2026

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: 07/05/2021
• Device Model Number: 29MJ-501
• Device Catalogue Number: 29MJ-501
• Device Lot Number: 5560378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 07/13/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2016
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male