MAUDE Adverse Event Report: ABBOTT MEDICAL Navitor Vision; Aortic Valve, Prosthesis, Percutaneously Delivered

Model Number	NVRO-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	06/26/2026
Type of Reportable Event	Serious Injury
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) 2026, a 23mm navitor vision valve was chosen for a procedure using a small flexnav delivery system.During procedure, a pre-dilation was performed with a 20mm non-abbott balloon.After the implant, an aortic stenosis was noted and a valve-in-valve procedure was performed.There was no delay in the procedure.The patient was reported stable.
Event or Problem Description
It was reported that on (b)(6) 2026, a 23mm navitor vision valve was chosen for a procedure using a small flexnav delivery system.The patient had previously implanted 19mm non-abbott valve.During procedure, a pre-dilation was performed with a 20mm non-abbott balloon.After the implant, an aortic stenosis was noted and a valve-in-valve procedure was performed.There was no delay in the procedure.The patient was reported stable.
Additional Manufacturer Narrative
An event of aortic valve stenosis was 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.Based on available information, the cause of the reported incident could not be conclusively determined.The reported valve-in-valve procedure was result of case specific circumstance, as a non-abbott valve had previously been implanted.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: Navitor Vision
• 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: 25896065
• Report Number: 2135147-2026-05006
• Device Sequence Number: 10149905
• Product Code: NPT
• UDI-Device Identifier: 05415067045805
• UDI-Public: (01)05415067045805(17)280525
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 09/29/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: NVRO-23
• Device Catalogue Number: NVRO-23
• Device Lot Number: 10910613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 07/21/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2025
• 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