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

Model Number	NVTR-27
Medical Device Problem Codes	Incomplete Coaptation (2507); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	06/04/2024
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.
Event or Problem Description
It was reported that on (b)(6) 2025, a 27mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).During the procedure, the valve was able to be implanted successfully.On (b)(6) 2025, a transesophageal echocardiogram (tee) revealed moderate to severe regurgitation and the bioprosthetic cusp in the traditional right coronary cusp position is not functioning and appears to be adherent to the anterior portion of the bioprosthetic stent.A valve-in-valve implantation was required.The patient was re-admitted in hospital.
Additional Manufacturer Narrative
An event of incomplete coaptation and central regurgitation were reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.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 to show adhered leaflet with a significant amount of regurgitation.Based on available information, the reported incomplete coaptation and central regurgitation could not be conclusively determined.The reported prolonged hospitalization was result of case specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Codes removed: health effect- impact code: 4624.
Event or Problem Description
It was reported that on (b)(6) 2025, a 27mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).During the procedure, the valve was able to be implanted successfully at a depth of 3mm on the non-coronary cusp (ncc).On (b)(6) 2025, a transesophageal echocardiogram (tee) revealed moderate to severe regurgitation and the bioprosthetic cusp in the traditional right coronary cusp position is not functioning and appears to be adherent to the anterior portion of the bioprosthetic stent.Valve-in-valve procedure was not performed since the patient reached an overall deconditioning with a risk to comorbidities.The patient was discharged with an intention of entering into a hospice care.

• 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: 23751809
• Report Number: 2135147-2025-07237
• Device Sequence Number: 14916471
• Product Code: NPT
• UDI-Device Identifier: 05415067031594
• UDI-Public: (01)05415067031594(17)260111
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: 01/11/2026
• Device Model Number: NVTR-27
• Device Catalogue Number: NVTR-27
• Device Lot Number: 8867447
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2023
• 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 Age: 69 YR
• Patient Sex: Female