MAUDE Adverse Event Report: Abbott Medical Navitor Transcatheter Aortic Valve; Aortic Valve, Prosthesis, Percutaneously Delivered

Model Number	NVTR-29
Medical Device Problem Codes	Material Split, Cut or Torn (4008); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	05/13/2026
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.
Event or Problem Description
(b)(4) vista nova, patient site id: (b)(6).\ \ it was reported that on (b)(6) 2024, a 29mm navitor valve was chosen for implant.It was then reported on (b)(6) 2026, patient presented with severe aortic regurgitation.A transesophageal echocardiogram on (b)(6) 2026 confirmed presence of central aortic regurgitation due to a leaflet tear.No intervention or medical treatment was reported.

• 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 ; +1(651)756-5400
• MDR Report Key: 50019961
• Report Number: 2135147-2026-05090
• Device Sequence Number: 9662364
• Product Code: NPT
• UDI-Device Identifier: 05415067031600
• UDI-Public: (01)05415067031600(17)260418
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/18/2026
• Device Model Number: NVTR-29
• Device Catalogue Number: NVTR-29
• Device Lot Number: 9234164
• 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: 07/01/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2023
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 125 LB