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

Model Number	NVRO-27
Medical Device Problem Codes	Perivalvular Leak (1457); Poor Visibility (4072)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 27mm navitor was chosen for implantation, utilizing a large flexnav.The patient presented with severe aortic stenosis, atrial fibrillation, right bundle branch block (rbbb), and calcification was confirmed from the annulus to the subvalvular to left ventricular outflow tract (lvot).It was noted that imaging difficulties occurred during the procedure.The valve was implanted at a depth of 4.6 mm on non-coronary cusp (ncc) and 3.3 mm on left coronary cusp (lcc).The procedure was completed.On (b)(6) 2026, the patient presented to the hospital with atrial fibrillation and symptomatic second-degree heart block.To treat the heart block, a permanent pacemaker was implanted on the same day.On (b)(6) 2026, an echocardiogram was performed and revealed mild paravalvular leak (pvl).The patient was reported to be stable and discharged to home.No additional information was provided.
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: 50859259
• Report Number: 2135147-2026-06407
• Device Sequence Number: 18530307
• Product Code: NPT
• UDI-Device Identifier: 05415067045799
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 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-27
• Device Catalogue Number: NVRO-27
• Device Lot Number: 11227829
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2026
• 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: Hospitalization; Required Intervention
• Patient Sex: Female