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

Model Number	NVRO-25
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Perivalvular Leak (1457); Off-Label Use (1494)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	07/28/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that on (b)(6) 2026, a 25 mm navitor vision valve was selected for a valve-in-valve procedure.The navitor valve was implanted within a 25 mm non-abbott surgical aortic valve that had been implanted in 2015.No pre-dilation was performed.The patient's aortic valve angle was reported as 43 degrees.During the procedure, the implant depth at approximately 80% deployment was reported as 4 mm at the non-coronary cusp (ncc) and 4 mm at the left coronary cusp (lcc).The navitor valve was successfully released; however, upon release, the non-marker side of the navitor valve moved upward.Immediately prior to migration, the implant depth of the navitor valve was reported as 2 mm below the 25 mm non-abbott valve frame.It was clarified that the valve moved superiorly toward the aortic arch.The final implant depth after migration was reported as 0.0 mm at the non-coronary cusp (ncc) and 2.0 mm at the left coronary cusp (lcc).Moderate to severe paravalvular leak (pvl) was observed.The implanter checked for non-uniform expansion (nue), and no nue was observed.No eccentric calcification or anatomical/tissue-calcium interference affecting valve expansion was reported.Post-dilation was performed using a 24 mm non-abbott balloon; however, moderate pvl persisted.As a result, the physician decided to implant a 23 mm non-abbott valve with an additional 2 cc added to the deployment balloon.The 23 mm non-abbott valve was implanted inside the 25 mm navitor valve, which was implanted inside the 25 mm non-abbott surgical aortic valve.Following implantation of the 23 mm non-abbott valve, the pvl was reduced to mild.The implanter was unsure of the cause of the migration.The echocardiogram closest to discharge demonstrated trace pvl.The patient remained hemodynamically stable throughout the procedure.No clinically significant delay was reported.The patient's status was reported as discharged.

• 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: 50379123
• Report Number: 2135147-2026-05756
• Device Sequence Number: 9736685
• Product Code: NPT
• UDI-Device Identifier: 05415067045782
• UDI-Public: (01)05415067045782(17)271009
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/21/2026

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-25
• Device Catalogue Number: NVRO-25
• Device Lot Number: 10618900
• 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: Not provided
• Initial Report FDA Received Date: 08/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2024
• 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: 72 YR
• Patient Sex: Male