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

Model Number	27MJ-501
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on 24 february 2025, a 27mm sjm masters series mechanical heart valve was chosen for a procedure.During procedure, the chief surgeon used standardized valve measurement methods to measure the size of the valve annulus during laparoscopic mitral valve replacement surgery.The surgeon experienced leaflet detachment while rotating the valve leaflets to check their opening and closing status after suturing the valve.The leaflet was dislodged into one piece and they confirmed the intact leaflet was recovered from the patient.In the end, the chief surgeon replaced the valve with a new 27mm sjm masters series mechanical heart valve.There was no leaflet detachment occurred when rotating the valve leaflets, and the surgery was very successful.There was no delay in the procedure.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
It was reported that after suturing the valve, leaflet detachment was experienced while rotating the valve leaflets to check opening and closing.Also reported that the leaflet was dislodged into one piece and they confirmed the intact leaflet was recovered from the patient.The valve was returned to abbott and the investigation found that both leaflets had fractured and were dislodged from the orifice.No other damage was noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The damage to leaflets may have been caused by some external force applied to the valve which overstressed the carbon material.While 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 leaflets.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: component code: 4755 part/component/sub-assembly term not applicable.Type of investigation: 4118 type of investigation not yet determined; investigation findings: investigation conclusions: 11 conclusion not yet available.

• 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: 21703037
• Report Number: 2135147-2025-01575
• Device Sequence Number: 15938154
• Product Code: LWQ
• UDI-Device Identifier: 05415067045034
• UDI-Public: (01)05415067045034(17)281216
• 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): 04/17/2025

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: 27MJ-501
• Device Catalogue Number: 27MJ-501
• Device Lot Number: C00017785
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2023
• 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