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

Model Number	NVRO-29
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
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 29mm navitor vision valve was selected for implant using a flexnav delivery system (ds).Pre-implant balloon aortic valvuloplasty (pre-bav) was performed by using a 24mm, unknown balloon.During the procedure, the valve repeatedly dived into the left ventricular outflow tract (lvot) and it was at a deeper position on the left-coronary cusp (lcc).After two unsuccessful deployments, it was decided to replace with a new system.On the first attempt, the valve was able to be deployed at a depth of 3-4mm on the non-coronary cusp (ncc).Post-implant, mild paravalvular leak (pvl) was observed.Post-implant balloon aortic valvuloplasty (post-bav) was performed by using a 24mm, unknown balloon.Trace pvl was observed.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported.The patient was discharged.
Event or Problem Description
It was reported that on (b)(6) 2026, a 29mm navitor vision valve was selected for implant using a flexnav delivery system (ds).Pre-implant balloon aortic valvuloplasty (pre-bav) was performed by using a 24mm, unknown balloon.During the procedure, the valve repeatedly dived into the left ventricular outflow tract (lvot) and it was at a deeper position on the left-coronary cusp (lcc).After two unsuccessful deployments, it was decided to replace with a new system.On the first attempt, the valve was able to be deployed at a depth of 3-4mm on the non-coronary cusp (ncc).Post-implant, mild paravalvular leak (pvl) was observed.Post-implant balloon aortic valvuloplasty (post-bav) was performed by using a 24mm, unknown balloon.Trace pvl was observed.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported.The patient was 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.
Additional Manufacturer Narrative
An event of perivalvular leak (pvl) and regurgitation was reported.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 the available information, the cause of the reported pvl could not be conclusively determined.It is possible that procedural factors and/or patient condition contributed to the reported event; however, this cannot be confirmed.The reported regurgitation are likely cascading effects of the reported pvl.The reported unexpected medical intervention were results 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.Cine review: "one (1) fluoroscopy video was provided.In the first 2 attempts there was no coaxial alignment of flexnav with the annulus.3rd attempt (with new system) was ok and after post-dilatation the result was good".

• 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: 50243941
• Report Number: 2135147-2026-05562
• Device Sequence Number: 21414866
• Product Code: NPT
• UDI-Device Identifier: 05415067045775
• UDI-Public: (01)05415067045775(17)290323
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 09/22/2026

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-29
• Device Catalogue Number: NVRO-29
• Device Lot Number: 11375587
• 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: 09/14/2026
• Initial Report FDA Received Date: 08/13/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2026
• 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 Age: 81 YR
• Patient Sex: Unknown