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

Catalog Number 21AGN-751

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 01/27/2024

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2024, a 21mm sjm regent heart valve was chosen for a procedure.The patient's inr ratio was 2.0~2.5.At the time of preparation, the leaflet was moving normally and it was tested by a leaflet tester.During procedure, it was noted that one of the leaflet was stacked and a gap was observed, so it was rotated and checked the leaflet was completely closed and the pump (artificial heart-lung apparatus) was turned off, but the leaflet was stacked again, resulting in severe aortic regurgitation (ar).The pump was turned on and the valve was explanted interprocedurally.The leaflets are moving normally after the explant procedure.A new 23mm epic valve was implanted as replacement.There was some delay in the procedure.The patient was reported stable.

Manufacturer Narrative

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

Manufacturer Narrative

An event of physical resistance/sticking of the leaflets was reported and did not confirmed.Morphological and hydrodynamic examination indicated the valve met abbott specifications.Hydrodynamic testing upon return to abbott and at the time of manufacturing indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 18748407
• MDR Text Key: 335933639
• Report Number: 2135147-2024-00786
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005982
• UDI-Public: (01)05414734005982(17)270525(10)8494466
• 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: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21AGN-751
• Device Lot Number: 8494466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2022
• 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
• Patient Age: 59 YR