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

Model Number	NVRO-29
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 29 mm navitor vision valve was selected for implant using a large flexnav delivery system.The patient had a history of right bundle branch block (rbbb), which was also the patient's baseline rhythm prior to the procedure.The membranous septum length was 2.5 mm.It was reported that there was no calcification extending beneath the aortic annular plane into the interventricular septum.During the procedure, while in the cusp overlap view (cov), the inflow edge of the constrained valve within the capsule was positioned at the base of the aortic annulus and the pigtail position was confirmed at the bottom of the non-coronary cusp (ncc).The initial implant depth was 3 mm; however, the valve was recaptured to achieve optimal depth on the left side.The final implant depth at release was 5 mm.A temporary pacemaker was used during the procedure, and the patient left the catheterization laboratory with the temporary pacemaker in place.Following the procedure, the patient's rhythm was reported to be similar, and the physician elected to observe the patient.The patient left the procedure room with rbbb, which was the same rhythm present prior to the procedure.The patient remained hemodynamically stable throughout the procedure.No clinically significant delay was reported.The patient was monitored with the temporary pacemaker in place.After observation, on (b)(6) 2026, the physician determined that a pacemaker was needed, and the patient received a permanent pacemaker.It was reported that the patient's pre-existing rbbb worsened 24 to 48 hours after the procedure, which led to the decision to implant a permanent pacemaker.The patient had a prolonged hospital stay for rhythm monitoring and remained an additional night in the hospital.The implanter classified the event as related to the procedure and the patient's past medical history.The patient's status was reported as stable and 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: 50261359
• Report Number: 2135147-2026-05614
• Device Sequence Number: 21363568
• Product Code: NPT
• UDI-Device Identifier: 05415067045775
• UDI-Public: (01)05415067045775(17)290201
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 08/28/2026

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-29
• Device Catalogue Number: NVRO-29
• Device Lot Number: 11289714
• 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: 07/21/2026
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2026
• 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
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Race: White