MAUDE Adverse Event Report: ABBOTT MEDICAL NAVITOR VISION; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	NVRO-35
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Off-Label Use (1494); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	02/25/2026
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) 2025, a 35mm navitor vision valve was selected for implant using a large flexnav delivery system.The patient had a type 1 bicuspid annulus with a calcified raphe.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed using an unknown balloon.During the procedure, incomplete stent opening (iso) was noted and mitigated as per the established steps and the valve was able to be implanted at a depth of 3mm both on the non-coronary cusp (ncc) and left-coronary cusp (lcc).Post-implant, moderate aortic regurgitation was noted and treated medically.Post-implant balloon aortic valvuloplasty (post-bav) was performed using a non-abbott balloon; regurgitation remained unchanged.On an unknown date, the patient was developed with heart failure.On (b)(6) 2026, a non-abbott valve was implanted by performing a valve-in-valve procedure resulting in no leak.The patient had an extended hospitalization.The patient was in a stable condition and subsequently discharged.
Event or Problem Description
It was reported that on (b)(6) 2025, a 35mm navitor vision valve was selected for implant using a large flexnav delivery system.The patient had a type 1 bicuspid annulus with a calcified raphe.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed using an unknown balloon.During the procedure, incomplete stent opening (iso) was noted and mitigated as per the established steps and the valve was able to be implanted at a depth of 3mm both on the non-coronary cusp (ncc) and left-coronary cusp (lcc).Post-implant, moderate aortic regurgitation was noted and treated medically.Post-implant balloon aortic valvuloplasty (post-bav) was performed using a non-abbott balloon; regurgitation remained unchanged.On an unknown date, the patient was developed with heart failure.On (b)(6) 2026, a non-abbott valve was implanted by performing a valve-in-valve procedure resulting in no leak.The patient had an extended hospitalization.The patient was in a stable condition and subsequently discharged.
Additional Manufacturer Narrative
An event of significant aortic valve regurgitation and incomplete stent opening 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 incomplete stent opening and aortic valve regurgitation 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 hospitalization, unexpected medical intervention, and surgical intervention were results of case-specific circumstances as post-implant valvuloplasty was performed, and subsequently another valve was implanted (valve-in-valve) post-procedure.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 ; 6517565400
• MDR Report Key: 24667106
• Report Number: 2135147-2026-01824
• Device Sequence Number: 12032050
• Product Code: NPT
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 06/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: NVRO-35
• Device Catalogue Number: NVRO-35
• Device Lot Number: 10578067
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 06/07/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male