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

Catalog Number 23AGN-751

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 334217213
• Report Number: 2135147-2024-00423
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006101
• UDI-Public: 05414734006101
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/31/2024
• Supplement Dates Manufacturer Received: 04/13/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male