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	07/16/2026
Type of Reportable Event	Serious Injury
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 navitor loading system and a small flexnav delivery system.During the procedure, pre-dilatation was performed using a 20 mm non-abbott balloon.The balloon diameter did not exceed the minimum annular diameter.The native annular measurements were reported as an annulus perimeter of 62.1 mm, a perimeter-derived diameter of 22 mm, an annular area of 357.5 mm², and an lvot measurement of 20.5 mm.In the user's opinion, there was sufficient calcium present to allow anchoring of the device, with a reported calcium score of approximately 1200.The patient's aortic valve angle was reported as rao 7 / cra 3 in 3-cusp view and rao 30 / cau 14 in alternative 2-cusp view.The implant depth at 80% deployment was reported as 2-3 mm.Prior to final deployment, the implanter reported that the delivery system was maintained in a neutral/slight forward-pressure position and that the guidewire was pulled to a mid-ventricular position to deflect the nosecone.All three tabs were reportedly confirmed released.After 80% deployment, the valve migrated during the final 10% of deployment and dove very low into the left ventricle (lv).The implant depth at release prior to migration was reported as 2-3 mm.The final implant depth of the valve after migration was reported as 12-15 mm.No attempt was made to snare or reposition the valve.No surgical intervention was required.No coronary artery obstruction related to the migrated valve was reported.No entanglement between the delivery system and the navitor valve was reported during removal of the delivery system.The valve was not resheathed more than two times, and no post-dilatation was performed.The implanter reported that the cause of the migration was unknown.The intervention performed to address the event consisted of implantation of a 23 mm non-abbott valve within the index navitor valve.No patient issues, adverse events, clinical signs, or symptoms were reported during or after the procedure.The patient remained hemodynamically stable throughout the procedure.No initial or prolonged hospitalization due to the event was reported, and no clinically significant delay occurred.The patient's status was reported as 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: 50209026
• Report Number: 2135147-2026-05479
• Device Sequence Number: 9915561
• Product Code: NPT
• UDI-Device Identifier: 05415067045782
• UDI-Public: (01)05415067045782(17)280915
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 09/22/2026

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-25
• Device Catalogue Number: NVRO-25
• Device Lot Number: 11074512
• 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: 07/16/2026
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FlexNav, FNAV-DS-SM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown