MAUDE Adverse Event Report: ABBOTT MEDICAL Navitor Vision; Aortic Valve, Prosthesis, Percutaneously Delivered

Model Number	NVRO-23
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	05/06/2026
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) (b)(4) it was reported that on (b)(6) 2026, a 23mm navitor vision valve was chosen for implant.Pre-implant balloon valvuloplasty was performed with an 18mm non-abbott balloon.During procedure, while in the cusp overlap view (cov), the inflow edge of the constrained valve within the capsule was positioned at the base of aortic annulus while the pigtail positioned was confirmed to be at the bottom of the non-coronary cusp (ncc).It was noted there was no calcification extending beneath the aortic annular plane in the interventricular septum.The implanting physician checked for non-uniform expansion prior to deployment.The navitor valve was not resheathed during procedure before final implant depth of 3.5mm between the intraventricular end of the valve to the ncc.A post-implant balloon valvuloplasty with a 20mm non-abbott balloon was performed to reduce mild paravalvular leak to none.Post-procedure but prior to discharge on (b)(6) 2026, the patient experienced left bundle branch block (lbbb).No treatment was reported.Patient status was reported stable.
Event or Problem Description
Crd_1059 - vista nova, patient site id: (b)(6) it was reported that on (b)(6) 2026, a 23mm navitor vision valve was chosen for implant.Pre-implant balloon valvuloplasty was performed with an 18mm non-abbott balloon.During procedure, while in the cusp overlap view (cov), the inflow edge of the constrained valve within the capsule was positioned at the base of aortic annulus while the pigtail positioned was confirmed to be at the bottom of the non-coronary cusp (ncc).It was noted there was no calcification extending beneath the aortic annular plane in the interventricular septum.The implanting physician checked for non-uniform expansion prior to deployment.The navitor valve was not resheathed during procedure before final implant depth of 3.5mm between the intraventricular end of the valve to the ncc.A post-implant balloon valvuloplasty with a 20mm non-abbott balloon was performed to reduce mild paravalvular leak to none.Post-procedure but prior to discharge on (b)(6) 2026, the patient experienced left bundle branch block (lbbb).No treatment was reported.Patient status was reported stable.
Additional Manufacturer Narrative
An event of paravalvular leak and heart block after implant was reported.Heart block is a well-recognized complication of transcatheter aortic valve implantation procedures associated with known risk factors including patient conditions, such as pre-existing arrhythmia, anatomical factors, such as calcification extending beneath aortic annular plane in the interventricular septum, and the depth of implant of the device.Possible causes for paravalvular leak are sizing of the valve, implant depth, calcium distribution, deployment difficulties and inadequate radial forces.Information from the field indicated that the final implant depth at non-coronary cusp (ncc) was 3.5 mm.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on all available information, the reported pvl could be due to procedural circumstances (implant depth).A cause for the reported heart block could be cascading effect reported pvl.However, this cannot be conclusively determined.The interventions performed were result of case specific circumstances as post implant valvuloplasty was performed.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 25382907
• Report Number: 2135147-2026-03758
• Device Sequence Number: 18472737
• Product Code: NPT
• UDI-Device Identifier: 05415067045805
• UDI-Public: (01)05415067045805(17)270923
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: NVRO-23
• Device Catalogue Number: NVRO-23
• Device Lot Number: 10557726
• 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: 05/11/2026
• Supplement Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 06/03/2026
• Supplement Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2024
• 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 Age: 85 YR
• Patient Sex: Female
• Patient Weight: 92 LB