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

Catalog Number	NVTR-25
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
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 25mm navitor valve was selected for implant.There was sufficient calcium to allow anchoring of the device in the opinion of the user.During the procedure, the valve was implanted at a depth of -3/-3 mm.It was then noted that the valve had popped-up toward the aorta.The physicians think they was due to a bad release of the tabs upon final deployment and catheter removal motion.A 23mm non-abbott valve was implanted valve-in-valve to resolve the event.The patient was fine at the end of the procedure.The patient remained hemodynamically stable and there was no clinically significant delay during the procedure.
Additional Manufacturer Narrative
The device was not returned for analysis.An event of migration and device malposition was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The provided imaging was reviewed by an abbott senior design/product development engineer.Based on all available information, causes for the reported migration and device malposition could not be conclusively determined.The reported surgery was the result of case-specific circumstances.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2025, a 25mm navitor valve was selected for implant.There was sufficient calcium to allow anchoring of the device in the opinion of the user.During the procedure, the valve was implanted at a depth of -3/-3 mm.It was then noted that the valve had popped-up toward the aorta.The physicians think they was due to a bad release of the tabs upon final deployment and catheter removal motion.A 23mm non-abbott valve was implanted valve-in-valve to resolve the event.The patient was fine at the end of the procedure.The patient remained hemodynamically stable and there was no clinically significant delay during 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: 21479932
• Report Number: 2135147-2025-00982
• Device Sequence Number: 3957301
• Product Code: NPT
• UDI-Device Identifier: 05415067031587
• UDI-Public: (01)05415067031587(17)270124(10)10205096
• 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): 03/26/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: NVTR-25
• Device Lot Number: 10205096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2025
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2024
• 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: Required Intervention
• Patient Sex: Unknown