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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.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 29mm sjm masters series mechanical heart valve was chosen for a mitral valve replacement by video-assisted thoracotomy.During procedure, at the end of the fixation of the prosthesis, they noticed a disappearance of a tab, which forced us to remove the implanted prosthesis and put another prosthesis back in.
Additional Manufacturer Narrative
An event of leaflet dislodgement observed during procedure was reported.The valve was returned with one leaflet had been dislodged but remained intact while the other leaflet had been fractured and bee dislodged from the orifice.The sewing cuff was intact and contained blood/body fluids and sutures.No damage was noted to the dislodged leaflet.The orifice was noted to be fractured.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 and renal failure could not be determined.The surgical intervention and hospitalization are case specific circumstances as the defective device was removed and patient had a prolonged stay in intensive care.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2025, a 29mm sjm masters series mechanical heart valve was chosen for a mitral valve replacement by video-assisted thoracotomy.During procedure, at the end of the fixation of the prosthesis, they noticed a disappearance of a tab, which forced us to remove the implanted prosthesis and put another prosthesis back in.The tab retrieved via sternotomy.They had to turn the extracorporeal circulation and clamp the aorta for a long time to look for the missing tab and convert to sternotomy to finally find it; as a result, the patient had a pathological awakening requiring prolonged mechanical ventilation and subsequently developed pneumonitis, anuric kidney failure treated with dialysis and a prolonged stay in intensive care.The procedure took least 3 hours longer than a normal intervention.The valve removed and new valve implanted while the patient was still on bypass.The patient was reported stable.

• 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: 24040396
• Report Number: 2135147-2026-00254
• Device Sequence Number: 13388136
• Product Code: LWQ
• UDI-Device Identifier: 05415067045058
• UDI-Public: (01)05415067045058(17)290427
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/02/2026

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: C00029864
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2025
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown