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 Codes	Aortic Valve Insufficiency/ Regurgitation (4450); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 27mm navitor vision valve was selected for implant using an unknown sized flexnav delivery system (ds).During the procedure, the valve was able to be implanted successfully.However, due to hypomobile leaflet it was decided to implant a second valve.A new 27mm navitor vision valve was selected for implant using an unknown sized flexnav ds.The valve was able to be implanted successfully.Unfortunately, this resulted in coronary occlusion.At an unspecified time on the same day, the patient had deceased.
Additional Manufacturer Narrative
The clip remains 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.
Additional Manufacturer Narrative
An event of incomplete coaptation and central regurgitation was reported.A returned device inspection could not be performed as the device 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.Based on the available information, the root cause for the reported events could not be conclusively determined.It is possible due to procedural condition and patient's condition; however, this cannot be confirmed.The reported unexpected medical intervention and surgical intervention were result of case specific circumstances as post-implant valvuloplasty and valve in valve was implanted.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: health effect-clinical code: 4582.
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).Pre-implant balloon aortic valvuloplasty (pre-bav) was performed using a 20mm, non-abbott balloon.During the procedure, the valve was able to be implanted successfully at a depth of 4mm on the non-coronary cusp (ncc).Severe central regurgitation was noted.Post-implant balloon aortic valvuloplasty (post-bav) was performed using an unknown balloon.Regurgitation remained severe.Due to hypomobile leaflet it was decided to implant a second valve.A new 27mm navitor vision valve was selected for implant using a large flexnav ds.The valve was able to be implanted at a depth of 1 to 2mm on the non-coronary cusp (ncc).Unfortunately, this resulted in coronary occlusion.The user attempted to snare the valve.Post-procedure less than two hours, the patient had deceased.

• 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: 23854462
• Report Number: 2135147-2025-07533
• Device Sequence Number: 12019562
• Product Code: NPT
• UDI-Device Identifier: 05415067031594
• UDI-Public: (01)05415067031594(17)280908
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 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 Model Number: NVTR-27
• Device Catalogue Number: NVTR-27
• Device Lot Number: 11063548
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2025
• 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: Required Intervention
• Patient Sex: Unknown