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

Catalog Number	31MJ-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	10/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2024, a 31mm masters valve was selected for implant.During the procedure, after implanting the valve, it was noticed that the valve fin came off in one piece.While still on bypass, the valve fin and device were removed from the patient, and a new valve was implanted.There was no clinically significant delay during the procedure.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of leaflet dislodgement was reported.The valve and dislodged leaflet were returned to abbott for investigation.The recessed pivot areas, pivot guards, intact leaflet and dislodged leaflet did not contain any visible evidence of surface damage or anomalies.The intact leaflet was properly inserted into the orifice and able to fully open and close with no resistance noted.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 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 leaflet.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) 2024, a 31mm masters valve was selected for implant.During the procedure, after implanting the valve, it was noticed that the valve fin came off in one piece.While still on bypass, the valve fin and device were removed from the patient, and a new valve was implanted.There was no clinically significant delay during the procedure.There were no adverse consequences to the patient.

• 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: 20791814
• Report Number: 2135147-2024-05652
• Device Sequence Number: 12453450
• Product Code: LWQ
• UDI-Device Identifier: 05415067045072
• UDI-Public: (01)05415067045072(17)281108(10)C00017021
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 31MJ-501
• Device Lot Number: C00017021
• 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: 10/14/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2023
• 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: Hospitalization
• Patient Sex: Unknown