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

Model Number	NVTR-25
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Arrhythmia (1721); Syncope/Fainting (4411); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
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
Clinical information: (b)(6) - vista nova study, patient site id: (b)(6).It was reported that on (b)(6) 2024, a 25mm navitor valve was successfully implanted a patient.A pre-implant balloon aortic valvuloplasty was performed using a 20mm non-abbott device.The inflow edge of the constrained valve frame was not aligned at the base of the non-coronary cusp.The valve was re-sheathed once during procedure due to being deployed too low.The final non-coronary cusp implant depth was 6mm.A post-implant balloon aortic valvuloplasty was performed using a 24mm non-abbott device due to valve under expansion.On (b)(6) 2025, it was noted that the patient was hospitalized due to recurrent syncope with falls.The patient was diagnosed with diagnosed sick sinus syndrome using a 24 hour electrocardiogram.The decision was made to implant a permanent pacemaker.
Additional Manufacturer Narrative
An event of syncope one year post-procedure was reported.Information from the field indicated that the patient effect is not related to the procedure or the navitor valve.There is no allegation of malfunction against the navitor valve.However, the device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.A returned device assessment could not be performed as the device was not returned for analysis.Based on the available information, there are no related patient effect to the navitor valve or procedure.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: health effect-clinical code: 1721 arrhythmia;4411 syncope/fainting.Health effect- impact code: 4624 surgical intervention; 4641 unexpected medical intervention; 4607 hospitalization or prolonged hospitalization.Medical device problem code: 1254 difficult to fold, unfold or collapse.
Event or Problem Description
Clinical information: (b)(6) - vista nova study, patient site id: (b)(6) - 1706 (b)(4).It was reported that on (b)(6) 2024, a 25mm navitor valve was successfully implanted a patient.A pre-implant balloon aortic valvuloplasty was performed using a 20mm non-abbott device.The inflow edge of the constrained valve frame was not aligned at the base of the non-coronary cusp.The valve was re-sheathed once during procedure due to being deployed too low.The final non-coronary cusp implant depth was 6mm.A post-implant balloon aortic valvuloplasty was performed using a 24mm non-abbott device due to valve under expansion.On (b)(6) 2025, it was noted that the patient was hospitalized due to recurrent syncope with falls.The patient was diagnosed with diagnosed sick sinus syndrome using a 24 hour electrocardiogram.The decision was made to implant a permanent pacemaker.No additional information was provided.

• 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: 22783782
• Report Number: 2135147-2025-04466
• Device Sequence Number: 21299452
• Product Code: NPT
• UDI-Device Identifier: 05415067031587
• UDI-Public: (01)05415067031587(17)260806
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/06/2026
• Device Model Number: NVTR-25
• Device Catalogue Number: NVTR-25
• Device Lot Number: 9216577
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 77 KG