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

Model Number	NVTR-23
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Death
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.The patient's condition prior to procedure was "good but fragile." pre-dilatation was not performed.During procedure, the valve was implanted as part of a valve-in-valve into a 21mm trifecta valve and post-dilatation was performed.After post-dilatation, the navitor valve "was carried into the aortic arch when the guide was removed." the implant depth at 80% was 0.5mm and the implant depth at release prior to migration was 0.5mm.The ds was in neutral position and the guidewire was in midventricular position prior to final deployment.The navitor valve was not snared into position and it did not block any arteries.There was no entanglement with the ds.There are no allegations of malfunction with the navitor valve.On (b)(6) 2025, the patient passed away due to unknown causes.The user suspects that the patient passing was related to the procedure.
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.
Additional Manufacturer Narrative
An event of migration or expulsion of device (aortic direction) 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, the cause for the reported device migration in aortic and death could not be determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Codes removed: medical device problem code: 2993 adverse event without identified device or use problem.
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.The valve was implanted as part of a valve-in-valve into a 21mm trifecta valve due to valve degeneration.The patient's condition prior to procedure was "good but fragile." the patient's aortic valve angle was noted as normal.Pre-dilatation was not performed.The implant depth at 80% was 5mm and the implant depth at release prior to migration was 5mm.The ds was in neutral position and the guidewire was in midventricular position prior to final deployment.Post-dilatation was performed.After post-dilatation, the navitor valve "was carried into the aortic arch when the guide was removed." the navitor valve was not snared into position and it did not block any arteries.There was no entanglement with the ds.There are no allegations of malfunction with the navitor valve.On (b)(6) 2025, the patient passed away due to unknown causes.The user suspects that the patient passing was related to the procedure.

• 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: 21609896
• Report Number: 2135147-2025-01315
• Device Sequence Number: 7554086
• Product Code: NPT
• UDI-Device Identifier: 05415067031570
• UDI-Public: (01)05415067031570(17)260903
• 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: 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): 04/22/2025

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: 09/03/2026
• Device Model Number: NVTR-23
• Device Catalogue Number: NVTR-23
• Device Lot Number: 10001138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2023
• 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: Death
• Patient Sex: Unknown