MAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS SERIES HEART COATED AORTIC VALVED GRAFT; HEART-VALVE, MECHANICAL

Model Number	25CAVGJ-514 00
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
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) 2024, a 25mm sjm masters series coated aortic valved graft was selected for implant.During the procedure, while suturing the valve, the physician noticed stains on the aortic valve graft tube.The device was removed and replaced.It was also noted that the leaflets didn't open and close smoothly.There were no adverse health consequences to the patient.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.The patient has been discharged.
Additional Manufacturer Narrative
An event of leaflets not opening/closing smoothly, and stains observed on the valve graft was reported.The device was returned to abbott for investigation.No anomalies were found with the valve leaflets with both leaflets able to fully open and close without resistance.The valve was able to be rotated without difficulty.The valve was sent for functional testing at the engineering test lab, which ensures proper leaflet coaptation, where it met functional specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, including functional testing, and the product met all specifications.Additionally, the device was sent to the science and technology (s&t) lab for further testing which revealed that the control region and foreign material spectra showed similar chemical compositions by fourier transform infrared spectroscopy (ftir), indicating the foreign material (fm) is likely the coating material.As a result of this finding, the reported foreign material was determined to be a potential product quality issue.Exception (issue) is initiated to further investigate this complaint.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.
Event or Problem Description
It was reported that on 05 nov.2024, a 25mm sjm masters series coated aortic valved graft was selected for implant.During the procedure, while suturing the valve, the physician noticed stains on the aortic valve graft tube.The device was removed and replaced.It was also noted that the leaflets didn't open and close smoothly.There were no adverse health consequences to the patient.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.The patient has been discharged.

• Brand Name: MASTERS SERIES HEART COATED AORTIC VALVED GRAFT
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2648612; lot 20 b st caguas; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20929042
• Report Number: 2135147-2024-06380
• Device Sequence Number: 12859674
• Product Code: LWQ
• UDI-Device Identifier: 05415067044099
• UDI-Public: (01)05415067044099(17)280816
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/05/2025

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: 25CAVGJ-514 00
• Device Catalogue Number: 25CAVGJ-514 00
• Device Lot Number: 9202060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2024
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2023
• 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 Sex: Unknown