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

Model Number	NVRO-27
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 27mm navitor vision valve was selected for implant using a flexnav delivery system (ds).Pre-implant balloon aortic valvuloplasty (pre-bav) was not performed.During the procedure, on the first attempt, the valve was placed at a depth of 3mm on the non-coronary cusp (ncc) and it was able to be implanted approximately at a depth of 3mm.Mild paravalvular leak (pvl) was performed.Post-implant balloon aortic valvuloplasty (post-bav) was performed by using a 22mm, non-abbott balloon.Aortogram was performed and upon removal of the pigtail, it got caught on the navitor valve.Following, the physician pulled the pigtail catheter, navitor valve had migrated to the ascending aorta.The valve was repositioned to a higher position in the ascending aorta using a snare to avoid coronary occlusion.A new 27mm, navitor vision valve was implanted at an optimal depth with no further issues by performing a valve-in-valve procedure.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported.The patient was in a stable condition.
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: 50818829
• Report Number: 2135147-2026-06304
• Device Sequence Number: 16007137
• Product Code: NPT
• UDI-Device Identifier: 05415067045799
• UDI-Public: (01)05415067045799(17)281207
• 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): 09/18/2026

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 Model Number: NVRO-27
• Device Catalogue Number: NVRO-27
• Device Lot Number: 11191095
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2025
• 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 Age: 81 YR
• Patient Sex: Female