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	05/27/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Crd_1059 - vista nova, patient site id: (b)(6).It was reported that on (b)(6) 2026, a 23mm navitor with radiopaque markers was chosen for implant.Post-procedure, an electrocardiogram noted complete atrial block.A permanent pacemaker was implanted on (b)(6) 2026.
Event or Problem Description
(b)(6) - vista nova, patient site id: (b)(6).It was reported that on (b)(6) 2026, a 23mm navitor with radiopaque markers was chosen for implant.There was no calcification extending beneath the aortic annular plane in the interventricular septum.While in the cusp overlap view (cov), the inflow edge of the constrained valve within the capsule positioned at the base of aortic annulus while the pigtail positioned was confirmed to be at the bottom of the non-coronary cusp.The implant depth from the non-coronary cusp (ncc) to the ventricular end of the frame was 5.6mm.Post-procedure, an electrocardiogram noted complete atrial block.A permanent pacemaker was implanted on (b)(6) 2026.The current patient status was reported discharged.
Additional Manufacturer Narrative
An event of heart block was reported post procedure.The reported surgical intervention was result of case specific circumstance as permanent pacemaker was implanted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the available information the cause for the reported heart block cannot be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: health effect- impact code: 4607.

• 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: 25599455
• Report Number: 2135147-2026-04302
• Device Sequence Number: 5533813
• Product Code: NPT
• UDI-Device Identifier: 05415067045805
• UDI-Public: (01)05415067045805(17)280511
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2026

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: 10885689
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Supplement Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 06/23/2026
• Supplement Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 110 LB