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

Catalog Number	21AHPJ-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	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2024, a 21mm masters aortic mechanical heart valve was selected for implant.During procedure, a leaflet sustained damage; a small fragment of the leaflet fractured near the costing edge of the leaflet.No instruments were in contact with the valve at the time the fracture was observed.No resistance was felt when rotating.It was exchanged for a new 19mm masters aortic mechanical heart valve, which was successfully implanted.The patient was reported to be in stable condition.Of note, the patient underwent a double valve replacement and an unknown sized valve was implanted into the mitral side.
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 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.

• 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: 21096013
• Report Number: 2135147-2025-00189
• Device Sequence Number: 21125050
• Product Code: LWQ
• UDI-Device Identifier: 05415067043597
• UDI-Public: (01)05415067043597(17)280502(10)C00011700
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 03/07/2025

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 Catalogue Number: 21AHPJ-505
• Device Lot Number: C00011700
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2023
• 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