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

Model Number	29MJ-501
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pneumonia (2011); Heart Failure/Congestive Heart Failure (4446)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 29mm sjm masters series mechanical heart valve was chosen for a procedure.During procedure, the physician already measured the defect and were about to begin suturing it and tried to insert the valve.At that moment, one of the valve leaflets detached, so it was decided to remove the entire valve.The detached leaflet was recovered from the patient in one piece.The defective valve was removed and replaced with a new one.The patient spent more time on cardiopulmonary bypass and more time in intensive care.The patient was placed on extracorporeal membrane oxygenation (ecmo) for ventricular failure.The procedure was completed successfully.The patient was reported stable.
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.
Additional Manufacturer Narrative
An event of leaflet dislodgement during procedure and explanted was reported.The valve was returned with leaflets intact.Both leaflets were able to fully open and close with no resistance occurring.The valve was able to be rotated freely.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The root cause of the leaflet dislodgement could not be conclusively determined; there was no evidence of material defect in the carbon coating that may have caused or contributed to the dislodged leaflet.The reported patient effects and unexpected medical intervention was result of case-specific circumstances as the valve was removed and another valve was implanted.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Per the information available abbott cannot further speculate on why the reported event occurred.

• 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 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22911844
• Report Number: 2135147-2025-04830
• Device Sequence Number: 9221507
• Product Code: LWQ
• UDI-Device Identifier: 05415067045058
• UDI-Public: (01)05415067045058(17)281001
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 11/19/2025

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: 29MJ-501
• Device Catalogue Number: 29MJ-501
• Device Lot Number: C00015875
• 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: 08/05/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 11/19/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown