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

Model Number	NVRO-25
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Stroke/CVA (1770); Movement Disorder (4412); Heart Block (4444)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 25mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).The patient did not have a history of right bundle branch block (rbbb), left bundle branch block (lbbb) and 1st/2nd atrioventricular block (av) block.The patient has a severely calcified leaflets with calcification extending in the left ventricular outflow tract (lvot).The patient's aortic valve angle was 52 degrees.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed by using a 20mm, non-abbott balloon.During the procedure, while advancement of the flexnav ds across the annulus, the patient developed with a complete atrioventricular (av) block.A temporary pacemaker was placed to stabilize the cardiac rhythm.At 80 percent deployment, an incomplete stent opening (iso) was observed then the valve was recaptured.On the second attempt, the valve was placed at a depth of 4mm on the non-coronary cusp (ncc), iso remained unchanged; however, it was full deployed in the native annulus at a depth of 4mm on the non-coronary cusp (ncc) and iso was observed to be less than prior to deployment.Post-implant balloon aortic valvuloplasty (post-bav) was performed by using a 22mm, non-abbott balloon to address the iso.During post-bav, the valve migrated towards the aorta to a depth of 0mm on the ncc.Permanent pacemaker was implanted to resolve the heart block; no additional intervention was performed for the migration.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported.Post-procedure on an unknown date, the patient was developed with stroke and presented with loss of sensation in the left extremity.The patient had recovered from the neurological symptoms; however, the patient had an extended hospitalization.
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: 50818971
• Report Number: 2135147-2026-06305
• Device Sequence Number: 21502845
• Product Code: NPT
• UDI-Device Identifier: 05415067045782
• UDI-Public: (01)05415067045782(17)290531
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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?: 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: 11490433
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Disability
• Patient Sex: Unknown