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

Catalog Number	23AGN-751
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	12/29/2023
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) 2023, an 23mm regent valve was selected for a procedure.During the procedure, both of the leaflets were dislodged.It is unknown if device was changed or treatment was provided.The patient is stable, no additional information was provided.
Additional Manufacturer Narrative
An event of leaflet dislodgement during procedure was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The device was returned to abbott and the analysis revealed that both leaflets of the valve had been dislodged, but only one was returned.Information from the field indicated that no resistance was felt while rotating the valve and no instruments made contact with the device.Based on the information received, the cause of the reported event could not conclusively be determined.
Event or Problem Description
It was reported that on (b)(6)2023, a 23mm regent valve was selected for a procedure.During the procedure, both of the leaflets were dislodged as a single piece and was recovered from the patient.A 23mm regent valve was implanted as a replacement.The patient is stable,.

• Brand Name: REGENT HEART VALVE
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18615100
• Report Number: 2135147-2024-00423
• Device Sequence Number: 7565211
• Product Code: LWQ
• UDI-Device Identifier: 05414734006101
• UDI-Public: 05414734006101
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 04/16/2024

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: 23AGN-751
• Device Lot Number: C00014102
• 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: 01/08/2024
• Supplement Date Received by Manufacturer: 04/13/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2023
• 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: Male