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

Model Number	31MJ-501
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pulmonary Edema (2020)
Date of Event	09/08/2025
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) 2025, a 31mm sjm masters series mechanical heart valve was implanted in the patient.On (b)(6) 2025, the patient admitted to hospital and intubated, with pulmonary edema.The mechanical valve was found to be malfunctioning.Intraoperatively, one valve leaflet was found to be missing.The valve was replaced with a new 31mm sjm masters series mechanical heart valve.The leaflet was identified on computed tomography (ct).A computed tomography (ct) scan revealed the leaflet within the abdominal aorta at the bifurcation.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of leaflet dislodgement and patient effect of pulmonary edema two months post mhv implant was reported.The valve was returned with an intact and mobile leaflet while the other leaflet had been dislodged and not returned.Biological material was noted on the cuff and pivot areas.The cuff contained small torn damage.The valve was unable to rotate freely.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The damage may have been caused by some external force applied to the valve which overstressed the carbon material.The cause of the leaflet dislodgment could not be conclusively determined.The cause of the patient effect pulmonary edema could not be determined.The surgical intervention and hospitalization are case specific circumstances as the defective device was removed and patient undergone rehabilitation.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 23352792
• Report Number: 2135147-2025-06034
• Device Sequence Number: 21014516
• Product Code: LWQ
• UDI-Device Identifier: 05415067045072
• UDI-Public: (01)05415067045072(17)290313
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 12/12/2025

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: 31MJ-501
• Device Catalogue Number: 31MJ-501
• Device Lot Number: C00028517
• 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: 09/26/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2025
• 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 Sex: Unknown