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

Model Number AGFN-756

Device Problems Incomplete Coaptation (2507); Patient Device Interaction Problem (4001)

Patient Problems Arrhythmia (1721); Thrombosis/Thrombus (4440)

Event Date 01/02/2023

Event Type  Injury  

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) 2022, a 21mm sjm regent heart valve w/flex cuff was successfully implanted.On an unknown date after the valve was implanted, the patient developed atrial arrhythmia.Thrombus formation was seen in the atria and led to fixation of one of the valve lobes.On (b)(6) 2023, re-operation was performed due to valve opening failure.During this procedure, it was seen that a ring-shaped thrombus had formed on the left atrial wall around the annulus and had spread to the mechanical valve.The left atrial side of the valve was covered by a thin thrombus like material.The valve was explanted.No additional information was provided.

Event Description

Subsequent to the previously filed report, additional information was received: it was noted that the valve remained open after thrombus occurred.

Manufacturer Narrative

Explant due to the valve not opening properly and a thrombus was reported.The investigation found that the mechanical leaflets opened and closed completely and were freely mobile.No material was seen within pivot recesses or adherent to mechanical leaflets.There was focal adherent dark red-brown material on the sewing cuff.A piece of material removed from the sewing cuff consists of fibrin and clotted blood.No inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and that the product met all specifications.The cause of the reported event could not be conclusively determined.

• Brand Name: REGENT HEART VALVE WITH FLEX CUFF
• 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: 16390261
• MDR Text Key: 309750029
• Report Number: 2135147-2023-00554
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005975
• UDI-Public: 05414734005975
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AGFN-756
• Device Catalogue Number: 21AGFN-756
• Device Lot Number: C00005363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2022
• 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 Outcome(s): Required Intervention; Hospitalization