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

Model Number	NVRO-27
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
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 large flexnav delivery system (ds).The patient had a severely calcified bicuspid aortic valve.The procedural strategy consisted of implanting the valve approximately 2 mm below the annular plane, targeting skirt positioning at the annulus to minimize the risk of paravalvular leak (pvl).The procedure was performed in the cusp overlap projection.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed by using a 22mm, non-abbott balloon.During the procedure, at 80 percent, angiographic confirmation was obtained in the left anterior oblique (lao) projection with parallax correction for detailed assessment of valve position.The valve position was considered appropriate and consistent with the pre-established procedural strategy.Upon final release, the valve was at a depth of 2mm and able to be implanted.Post-implant, the valve had migrated towards the ascending aorta.The valve was repositioned using a snare and secured in a stable position within the aorta.A second 27mm, navitor vision valve was implanted by performing a valve-in-valve procedure to resolve the event resulting in satisfactory prosthesis positioning and function, with an acceptable final procedural outcome.The implanter believed the cause of migration to be due to the bicuspid type 1 - l-r calcified aortic root characteristic.
Additional Manufacturer Narrative
The device 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.

• 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: 50847653
• Report Number: 2135147-2026-06392
• Device Sequence Number: 9508522
• Product Code: NPT
• UDI-Device Identifier: 05415067045799
• UDI-Public: (01)05415067045799(17)281028
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 09/21/2026

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: 11142890
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2025
• 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: 73 YR
• Patient Sex: Male