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

Model Number	NVRO-25
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, a 25 mm navitor vision valve was selected for implant using a small flexnav delivery system.During the procedure, it was reported that the valve was implanted too high at a final implant depth of 1 mm on the non-coronary cusp.A post-balloon aortic valvuloplasty was performed using a 22 mm non-abbott balloon to address and resolve valve under expansion.It was reported that there were concerns that the valve would embolize.As a result, a second small flexnav delivery system was opened in preparation for implantation of a second valve; however, a second valve was ultimately not required as the valve did not embolize.The delivery system was not used and was reportedly discarded at the site.The patient did not have any clinical signs or symptoms or experience any issues or adverse events during or after the procedure.There was no clinically significant delay, and the patient remained hemodynamically stable throughout the procedure.The user believed the valve expanded non-uniformly due to excess calcium.The patient's status was reported as stable and discharged.
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.

• 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: 50801535
• Report Number: 2135147-2026-06268
• Device Sequence Number: 21485430
• Product Code: NPT
• UDI-Device Identifier: 05415067045782
• UDI-Public: (01)05415067045782(17)280317
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 09/17/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: NVRO-25
• Device Catalogue Number: NVRO-25
• Device Lot Number: 10808053
• 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: 08/21/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2025
• 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
• Patient Sex: Unknown