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

Model Number	NVTR-23
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	12/04/2025
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 23mm navitor vision valve was selected for implant using a small flexnav delivery system (ds).Pre-implant balloon aortic valvuloplasty (pre-bav) was performed using a 20mm, non-abbott balloon.During the procedure, the valve was able to be implanted.Post-implant, it was observed that the valve cells in the non-coronary sinus did not expand.Post-implant balloon aortic valvuloplasty (pre-bav) was performed using an unknown sized, non-abbott balloon.Valve regurgitation was noted necessitating to use an unspecified, non-compliant balloon.Subsequently, the valve popped up on the non-coronary sinus (ncc).At this point, echocardiogram (echo) showed significant valve regurgitation and high gradient.A new 23mm, navitor vision valve was implanted using a new flexnav ds.Gradient was measured as 4 mmhg.The patient was in a stable condition.
Event or Problem Description
It was reported that on (b)(6) 2025, a 23mm navitor valve was selected for implant using a small flexnav delivery system (ds).The patient's aortic valve angle was measured to be 43 degrees.Pre-implant balloon aortic 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 3mm on the non-coronary cusp (ncc).Post-implant, it was observed that the valve cells in the non-coronary sinus did not expand and there was no calcium to hinder this opening.Post-implant balloon aortic valvuloplasty (post-bav) was performed using an 22mm, non-abbott balloon; however, full expansion of the cell was not achieved since severe paravalvular leak (pvl) was noted.Subsequently, the valve popped up on the non-coronary sinus (ncc).At this point, echocardiogram (echo) showed significant valve regurgitation and high gradient.A new 23mm, navitor valve was implanted using a new flexnav ds.Gradient was measured as 4 mmhg.The patient remained hemodynamically stable throughout the procedure, and there was no clinically significant delay reported.The implanter believes failure in valve expansion as the cause of migration.The patient was discharged in a stable condition.
Additional Manufacturer Narrative
An event of valve under expansion, migration and regurgitation was reported.Field indicated that valve was implanted at optimal depth at 3 mm, however following implant the valve did not expand as there was no calcium to hinder opening.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the reported events of valve under expansion, migration and regurgitation appear to be cascading effects of initial incomplete expansion.However, the exact cause could not be conclusively determined.There was unexpected medical intervention as a result of case-specific circumstance, a post-implant balloon aortic valvuloplasty was performed due to valve regurgitation.However, the valve migrated and echocardiogram showed significant valve regurgitation and high gradient.A surgical intervention was performed due to valve-in-valve implant.Reportedly, the patient was discharged in a stable condition.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.

• Brand Name: NAVITOR TRANSCATHETER AORTIC VALVE
• 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: 23950773
• Report Number: 2135147-2026-00048
• Device Sequence Number: 20819908
• Product Code: NPT
• UDI-Device Identifier: 05415067031570
• UDI-Public: (01)05415067031570(17)260212
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 03/11/2026

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 Expiration Date: 02/12/2026
• Device Model Number: NVTR-23
• Device Catalogue Number: NVTR-23
• Device Lot Number: 8920356
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2023
• 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: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Unknown