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); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
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 35mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).Pre-implant balloon aortic valvuloplasty (pre-bav) was performed using a 25mm, unknown balloon.It was noted that the pre-bav was performed with a balloon not less than or equal to the minimum annulus diameter.During the procedure, at first attempt, the valve noted to have an incomplete stent opening (iso) was observed and a recapture was performed.At the second deployment, it was reported to be badly opened with a palmito shaped, and the valve was implanted.Post-implant balloon aortic valvuloplasty (post-bav) was performed using a 28mm, non-abbott balloon.A 29mm non-abbott valve was implanted to circularize the stent, functionally and hemodynamically good result with no post-procedure complications for the patient.The patient remained hemodynamically stable throughout the procedure, and there was no clinically significant delay reported.The patient was discharged.
Additional Manufacturer Narrative
An event of a device deformation and incomplete stent opening 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 information received from the field and cine review, the root cause of the reported device deformation and incomplete stent opening could not be conclusively determined.An unexpected medical and surgical intervention were results of case-specific circumstances, as a post implant valvuloplasty and valve-in-valve interventions were performed.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: medical device problem code: 2017.
Event or Problem Description
It was reported that on (b)(6) 2026, a 35 mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).Pre-implant balloon aortic valvuloplasty (pre-bav) was performed using a 25 mm, non-abbott balloon.The implanter believes the cause of slipping due to calcification.It was noted that the pre-bav was performed with a balloon not less than or equal to the minimum annulus diameter.During the procedure, at first attempt, the valve noted to have an incomplete stent opening (iso) was observed and a recapture was performed.At the second deployment, it was reported to be abnormally opened with an irregular (palmito) shaped, and the valve was implanted.On angiogram, it revealed a loss of circular stent geometry with an inward indentation.Post-implant balloon aortic valvuloplasty (post-bav) was performed using a 28 mm, non-abbott balloon.A 29 mm non-abbott valve was implanted to circularize the stent, functionally and hemodynamically good result with no post-procedure complications for the patient.The patient remained hemodynamically stable throughout the procedure, and there was no clinically significant delay reported.The patient was discharged.

• 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: 24338675
• Report Number: 2135147-2026-00921
• Device Sequence Number: 4812391
• Product Code: NPT
• UDI-Device Identifier: 05415067045768
• UDI-Public: (01)05415067045768(17)280505
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NVRO-35
• Device Catalogue Number: NVRO-35
• Device Lot Number: 10880141
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FNAV-DS-LG
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown