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

Catalog Number	23AGFN-756
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2023
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 regent aortic mechanical heart valve with flex cuff was chosen for implant.After the valve was successfully implanted, the valve leaflets could not open or close.During the attempt to adjust the opening and closing direction of the valve, using surgical forceps, a small piece of the valve orifice was noted to crack.The valve was removed and a replacement 23mm regent aortic mechanical heart valve with flex cuff was successfully implanted.The patient is reported to be stable.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
An event of the leaflets not moving once the valve was implanted and the valve chipping during an attempt to rotate the valve 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 investigation confirmed that both leaflets moved with ease under non-physiological conditions.The pivot guard was chipped.Information from the field indicated the orifice chipped while they were attempting to rotate the valve, which could have caused the damage noted.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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): 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: 18240923
• Report Number: 2135147-2023-05270
• Device Sequence Number: 14253421
• Product Code: LWQ
• UDI-Device Identifier: 05414734006095
• UDI-Public: 05414734006095
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/23/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 23AGFN-756
• Device Lot Number: C00006966
• 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: 11/05/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2022
• 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 Age: 49 YR
• Patient Sex: Male
• Patient Weight: 75 KG