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

Model Number	23AGFN-756
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
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, a 23mm sjm regent heart valve w/flex cuff was chosen for implant.After the valve was implanted, the valve was attempted to twist but the valve would not rotate.It was noted that the patient had a small left ventricular outflow tract (lvot).It appeared that one of the valve leaflets would not open properly.The valve was explanted and a 21mm non-abbott valve was implanted intraoperatively.There was no clinically significant delay in the procedure and the patient remained hemodynamically stable throughout.The patient was reported as stable.
Additional Manufacturer Narrative
An event of difficulty rotating the valve and the valve leaflets being unable to open and close smoothly was reported.The investigation found that the mechanical leaflets opened and closed completely and were freely mobile.In addition, the sewing cuff was intact, and light brown in color.Morphological and hydrodynamic examinations indicated that the valve met abbott specifications.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 incident could not be conclusively determined.
Event or Problem Description
It was reported that on (b)(6) 2023, a 23mm sjm regent heart valve w/flex cuff was chosen for implant.After the valve was implanted, the valve was attempted to twist but the valve would not rotate.It was noted that the patient had a small left ventricular outflow tract (lvot).It appeared that one of the valve leaflets would not open properly.The valve was explanted and a 21mm non-abbott valve was implanted intraoperatively.There was no clinically significant delay in the procedure and the patient remained hemodynamically stable throughout.The patient was reported as stable.Subsequent to the initially filed report, the following information was received that the valve leaflets were not moving well when they were being tested during device preparation.

• Brand Name: REGENT HEART VALVE WITH FLEX CUFF
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16709778
• Report Number: 2135147-2023-01561
• Device Sequence Number: 6111870
• Product Code: LWQ
• UDI-Device Identifier: 05414734006095
• UDI-Public: 05414734006095
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2023

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: 23AGFN-756
• Device Catalogue Number: 23AGFN-756
• Device Lot Number: C00007843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2023
• 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 Age: 53 YR
• Patient Sex: Male