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

Model Number	19AHPJ-505
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	09/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, a 21mm sjm regent heart valve was chosen for aortic valve insufficiency.During procedure, when the valve was placed on the annulus, and started stitching the valve at the time one leaflet of the valve separated from its hinge and fell into the heart.The valve was removed and all pieces of the device were removed from the patient.A new 19mm sjm regent heart valve was chosen and completed the procedure.The pump and cross clamp was extended.The patient was reported discharged form the hospital.
Event or Problem Description
It was reported that on (b)(6) 2024, a 21mm sjm regent heart valve was chosen for aortic valve insufficiency.During procedure, one leaflet of the valve separated from its hinge and fell into the heart.The valve was removed and a new 19mm sjm regent heart valve was chosen and completed the procedure.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.D4: the udi number is not known as the lot number was not provided.
Additional Manufacturer Narrative
Subsequent to the previously filed report, additional information was received as the event is downgraded into non reportable.Leaflet dislodgement is not considered a reportable event intraoperatively as the cause is due to failure to follow the ifu or to an external force applied to the valve (leaflet and orifice), which overstressed the carbon material, resulting in the dislodgement.Per 90407741, to be non-reportable, all pieces of the device are confirmed removed, there was no clinically significant prolongation of the procedure (inclusive of bypass time), and there was no hemodynamic instability.The initial report was previously filed; therefore, a supplemental report was submitted the lot number is added.
Additional Manufacturer Narrative
The reported event of a dislodged leaflet could not be confirmed.The investigation at abbott found the valve with both leaflets intact.Bottom rim of the valve noted to be chipped.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.While the root cause of the damage noted on the valve could not be conclusively determined, there was no evidence of material defect in the carbon coating that may have caused or contributed to the event.The noted damage may have been caused by some external force applied to the valve which overstressed the carbon material.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
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: 20344155
• Report Number: 2135147-2024-04820
• Device Sequence Number: 18156385
• Product Code: LWQ
• UDI-Device Identifier: 05415067043573
• UDI-Public: (01)05415067043573(17)280528
• 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,Followup
• Report Date (Section B): 11/07/2025

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: 19AHPJ-505
• Device Catalogue Number: 19AHPJ-505
• Device Lot Number: C00012592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 11/21/2024; 10/13/2025
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/22/2024; 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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