MAUDE Adverse Event Report: ABBOTT MEDICAL NAVITOR TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	NVTR-27
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Dyspnea (1816); Thrombosis/Thrombus (4440); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	07/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.B3: event date was estimated.
Event or Problem Description
It was reported in (b)(6) 2024 a 27mm navitor transcatheter aortic valve was implanted.In the beginning of may 2024, the patient presented with shortness of breath and was diagnosed with hypoattenuating leaflet thickening (halt).On (b)(6) 2024 the patient presented with transvalvular aortic regurgitation and a leaflet thrombosis was discovered on computed tomography (ct).Warfarin was initiated as treatment.The patient status was stable.
Additional Manufacturer Narrative
An event of patient device interaction problem associated with thrombus, and patient-device incompatibility was reported.A returned device assessment could not be performed as the device reamins implanmted and was not returned for analysis.Information from field indicated that warfarin was administerd as treatment for thrombus.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Imaging received appeared unclear to understand if some thrombus is on the leaflets.Based on received information the cause of reported patient device interaction problem could not be determined.The cause for the reported patient device interaction problem associated with hypoattenuating leaflet thickening could not be determined.It is possible due to procedural conditions such as valve under-expansion; however, this cannot be confirmed.The reported hospitalization, and unexpected medical intervention were result of case-specific circumstances as the patient returned to the hospital, medications were provided.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported in (b)(6) 2024 a 27mm navitor transcatheter aortic valve was implanted.In the beginning of (b)(6) 2024, the patient presented with shortness of breath and was diagnosed with hypoattenuating leaflet thickening (halt).On (b)(6) 2024 the patient presented with transvalvular aortic regurgitation and a leaflet thrombosis was discovered on computed tomography (ct).Warfarin was initiated as treatment.The patient status was stable.

• Brand Name: NAVITOR TRANSCATHETER AORTIC VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22459893
• Report Number: 2135147-2025-03744
• Device Sequence Number: 8560033
• Product Code: NPT
• UDI-Device Identifier: 05415067031594
• UDI-Public: (01)05415067031594(17)260613
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 08/26/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/13/2026
• Device Model Number: NVTR-27
• Device Catalogue Number: NVTR-27
• Device Lot Number: 9132778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 08/16/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown