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

Model Number	NVRO-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	08/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 23mm navitor vision valve was chosen for implantation, utilizing a small flexnav delivery system.The patient presented in sinus rhythm with pre-existing trifascicular conduction disease and no noted calcification extending beneath the aortic annular plane in the interventricular septum.It was noted that annulus measurements were within range for a 23mm navitor vision valve.Vascular access was obtained via left transaxillary approach.A 14 fr sheath was then introduced.An 18 mm cristal balt balloon was then inserted through the 14 fr sheath, and predilatation was performed.The 14 fr sheath was then removed from the patient.A small flexnav delivery system (ds) was then inserted and advanced into the left axillary artery.However, resistance was encountered during insertion.Therefore, the vessel was dilated using a 16 fr sheath.The flexnav was then attempted to advance again, but persistent resistance was encountered, and the flexnav was unable to advance.Therefore, a 18 fr gore dryseal sheath was then inserted, but resistance was encountered.Therefore, only the dilator of the 18 fr dryseal sheath was used to dilate the vessel, and the dilator was successfully advanced.A new attempt to advance the small flexnav delivery system was performed, and after modification of the insertion angle, the flexnav delivery system was successfully advanced without resistance.The 23mm navitor vision valve was then implanted at a depth of 4mm, following a partial recapture maneuver.It was noted that while in the cusp overlap view (cov), the inflow edge of the constrained valve was within the capsule positioned at the base of aortic annulus while the pigtail positioned was confirmed to be at the bottom of the ncc.However, immediately after valve deployment, the patient developed a complete atrioventricular block.A temporary pacemaker had already been placed at the beginning of the procedure due to a pre-existing conduction disease.During access site closure, an axillary artery perforation was observed, resulting in arterial occlusion.A vascular surgeon was then consulted urgently and joined the procedure for management of the vascular complication.The patient remained hemodynamically stable throughout the procedure.The patient was hospitalized to monitor the patient's rhythm.\ on an unknown date, a permanent pacemaker was implanted.The patient was reported to be stable.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: 50875621
• Report Number: 2135147-2026-06451
• Device Sequence Number: 9314296
• Product Code: NPT
• UDI-Device Identifier: 05415067045805
• UDI-Public: (01)05415067045805(17)281202
• 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,Followup
• Report Date (Section B): 10/01/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: NVRO-23
• Device Catalogue Number: NVRO-23
• Device Lot Number: 11189961
• 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: 08/31/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 09/23/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2025
• 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; Hospitalization
• Patient Sex: Unknown