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

Model Number	NVRO-23
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Perivalvular Leak (1457); Off-Label Use (1494)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
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
It was reported that on (b)(6).2026, a 23mm navitor vision valve was selected for implant using a small flexnav delivery system (ds).The patient has a prior medical history of being implanted with a 21mm, non-abbott surgical valve which is now degenerated.Pre-implant balloon valvuloplasty (pre-bav) was performed using a 20mm, non-abbott balloon.During the procedure, the valve was able to be implanted at a depth of 3.5mm on the non-coronary cusp (ncc).An incomplete stent opening (iso) was observed; post-implant, paravalvular leak (pvl) was observed.Post-implant balloon valvuloplasty (post-bav) was performed using a 22mm, non-abbott balloon for an unknown reason.No paravalvular leak (pvl) was observed; mean gradient was 12mmhg.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.The patient was in a stable condition.
Event or Problem Description
It was reported that on 06 may.2026, a 23mm navitor vision valve was selected for implant using a small flexnav delivery system (ds).The patient has a prior medical history of being implanted with a 21mm, non-abbott surgical valve which is now degenerated.Pre-implant balloon valvuloplasty (pre-bav) was performed using a 20mm, non-abbott balloon.During the procedure, the valve was able to be implanted at a depth of 3.5mm on the non-coronary cusp (ncc).An incomplete stent opening (iso) was observed and able to be mitigated as per the established steps; post-implant, paravalvular leak (pvl) was observed.Post-implant balloon valvuloplasty (post-bav) was performed using a 22mm, non-abbott balloon.No paravalvular leak (pvl) was observed; mean gradient was 12mmhg.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.The patient was in a stable condition.
Additional Manufacturer Narrative
An event of valve under-expansion, aortic valve regurgitation, and paravalvular leak was reported.A returned device assessment could not be performed as the device remains implanted and 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 information received, the cause of the reported incident could not be conclusively determined.The reported paravalvular leak appears to be a result of the incomplete expansion.The additional post-implant bav procedure was the result of case-specific circumstances as it was performed to mitigate the paravalvular leak.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: 25333993
• Report Number: 2135147-2026-03661
• Device Sequence Number: 9619252
• Product Code: NPT
• UDI-Device Identifier: 05415067045805
• UDI-Public: (01)05415067045805(17)281007
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/29/2026

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: 11180217
• 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: 05/06/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2025
• 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: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female