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

Model Number	NVRO-29
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Perivalvular Leak (1457)
Health Effect - Clinical Codes	Heart Block (4444); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	07/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 29mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).The patient has a prior medical history of atrial fibrillation.The patient's aortic valve angle was 47 degrees.There was severe annulus calcification extending below annulus into left ventricular outflow tract (lvot).Pre-implant balloon aortic valvuloplasty (pre-bav) was performed by using a 23mm, non-abbott balloon.With a non-abbott wire while pacing at 180 beats per minute.Post pre-bav, the patient went into a complete heart block.During the procedure, ds's inflow edge was passed beyond the annulus then it was attempted to deploy.On the first attempt, it was positioned to be high, so it was recaptured.On the second attempt, the valve was placed at a depth of 4mm both on the non-coronary cusp (ncc) and left-coronary cusp (lcc).Upon release, the valve was at a depth of 3mm on the ncc and 4mm on the lcc.Temporary pacemaker was left in place at the end of the procedure to stabilize the rhythm.Post-implant, mild/moderate paravalvular leak was observed with a gradient of 2mmhg.Post-implant balloon aortic valvuloplasty (post-bav) was performed by using a 25mm, non-abbott balloon.Post-intervention, mild pvl was noted.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported.A permanent pacemaker was implanted to resolve the event (heart block).The implanter believed the cause of migration to be due to the excess calcium.The implanter classified this event (heart block) as being related to the procedure and past medical history.The patient was in a stable condition and subsequently 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: 50179574
• Report Number: 2135147-2026-05408
• Device Sequence Number: 18606862
• Product Code: NPT
• UDI-Device Identifier: 05415067045775
• UDI-Public: (01)05415067045775(17)281214
• 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): 08/07/2026

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-29
• Device Catalogue Number: NVRO-29
• Device Lot Number: 11194184
• 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: 07/14/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2025
• 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: 85 YR
• Patient Sex: Male