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

Model Number	NVRO-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Heart Block (4444); Aortic Valve Insufficiency/ Regurgitation (4450)
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 25mm navitor vision valve was selected for implant using a 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 length of the membranous septum was less than 3mm.There was calcification extending beneath the aortic annular plane in the interventricular septum.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed by using an 18mm, non-abbott balloon.The patient was developed with a complete heart block.During the procedure, the valve was able to be implanted at a depth of 0mm on the non-coronary cusp (ncc) and 3mm on the left-coronary cusp (lcc).An unspecified grade of paravalvular leak was observed and a post-implant balloon aortic valvuloplasty (post-bav) was performed by using a 20mm, non-abbott balloon.A temporary pacemaker was placed to stabilize the rhythm.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported.Post-procedure later that day, a permanent pacemaker was implanted to resolve the event.The patient was discharged.The implanter classified this event as being related to the performance of the non-abbott pre-bav device.
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: 50417853
• Report Number: 2135147-2026-05787
• Device Sequence Number: 10110760
• Product Code: NPT
• UDI-Device Identifier: 05415067045782
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 09/24/2026

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-25
• Device Catalogue Number: NVRO-25
• Device Lot Number: 11328851
• 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
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2026
• 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
• Patient Sex: Unknown