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

Model Number	19AGN-751
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, a 19mm regent aortic mechanical heart valve was selected for an implanted.During the procedure after the implantation, it was noticed that valve could not be rotated and one of the leaflet of the valve was not closing properly, resulting in acute aortic incompetency.The valve was explanted and a non-abbott device was implanted.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of a inability to rotate a valve, and a valve not closing properly resulting in acute aortic incompetency was reported.The investigation found that both leaflets were intact and undamaged and that the valve rotated freely.Possible causes of inability to rotate the valve or the leaflet not moving are that the valve was oversized or that there was interaction with the anatomy.Information from the field indicated that the replacement valve was of the same size.Whether there was interaction with anatomy is unknown.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The root 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.
Event or Problem Description
It was reported that on (b)(6) 2023, a 19mm regent aortic mechanical heart valve was selected for an implanted.During the procedure after the implantation, it was noticed that valve could not be rotated and one of the leaflet of the valve was not closing properly, resulting in acute aortic incompetency.The valve was explanted and a non-abbott device was implanted.The patient was reported to be in stable condition.

• 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: 16304049
• Report Number: 2135147-2023-00399
• Device Sequence Number: 17663896
• Product Code: LWQ
• UDI-Device Identifier: 05414734005869
• UDI-Public: 05414734005869
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 05/03/2023

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 Model Number: 19AGN-751
• Device Catalogue Number: 19AGN-751
• Device Lot Number: C00006359
• 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: 01/12/2023
• Supplement Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2022
• 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