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

Catalog Number	19AHPJ-505
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/23/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2024, a 19mm sjm masters series hemodynamic plus valve was chosen for a procedure.During procedure, while the valve was positioned with its own holder, both leaflets were separated and fell into the left ventricle.One of the leaflets was removed, but when the other leaflet was not seen, the valve that was placed and the leaflet was removed was removed again.When the other leaflet could not be found in the left ventricle from the aortic angle, the artificial mitral valve that had been placed was also removed again.Despite all searches, a leaflet could not be found.When a leaflet could not be found with both sterile camera and scopy, a new 19mm sjm masters series hemodynamic plus valve was implanted.After the air in the cardiac chambers was removed, the aortic cross-clamp was removed and the heart was started.The patient hemodynamics were stabilized with inotropic support, was taken off the pump, decannulated, and after other procedures, the patient was taken to the intensive care unit.After the procedure, the patient had multiorgan failure developing after prolonged cardiopulmonary bypass period.On (b)(6) 2024, the patient was reported passed away.The cause of death was multiorgan failure that developed after a very long aortic cross clamp period and cardiopulmonary bypass period due to intracardiac search of the removed leaflet.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
An event of a leaflet fracture during implant and patient death was reported.The device was returned to abbott for investigation and found the device was returned with a torn cuff, one fractured leaflet and chipped /fracture damage on the bottom rim and butterfly wall area.It was indicated that leaflet could not be found in the left ventricle from the aortic angle, the artificial mitral valve that had been placed was also removed again.Regardless, the other leaflet was not found.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.The cause of the reported event of leaflet fractureand torn cuff is consistent with rotating the valve through resistance but could not be confirmed.The cause of death was due to prolonged operative conditions on intracardiac search of the removed leaflet.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.From medical review: "the patient death is procedure related due to a prolonged procedure causing a prolonged cardiopulmonary bypass and leading to multi-system organ failure post-operatively.It is unclear why the two leaflets dislodged from the valve at the time of positioning, but may be a result of applying excessive force during seating causing the carbon orifice to become ovalized with both leaflets falling out.".
Event or Problem Description
N/a.

• Brand Name: MASTERS SERIES HEMODYNAMIC PLUS 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: 21173200
• Report Number: 2135147-2025-00330
• Device Sequence Number: 9545855
• Product Code: LWQ
• UDI-Device Identifier: 05415067043573
• UDI-Public: (01)05415067043573(17)280327(10)C00010441
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 03/11/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 19AHPJ-505
• Device Lot Number: C00010441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2023
• 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: Death
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 56 KG