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

Model Number	NVRO-25
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, a 25mm navitor vision valve was selected for implant using a flexnav delivery system (ds).The patient's aortic valve angle was measured to be 54 degrees.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed by using a 23mm, non-abbott balloon.During the procedure, starting from stent inflow of the valve being position at the level of the non-coronary cusp (ncc) pigtail.Following inflow edge of navitor valve 3mm below the pig tail; upon release, the valve had migrated 7mm into the ventricle.No second valve was required to be implanted.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported.The implanter believed the cause of migration to be due to the valve didn't have enough radial force.The patient was reportedly discharged.
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: 50818616
• Report Number: 2135147-2026-06302
• Device Sequence Number: 10158246
• Product Code: NPT
• UDI-Device Identifier: 05415067045782
• UDI-Public: (01)05415067045782(17)290524
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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?: 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: 11479759
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2026
• 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: Female