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

Model Number	NVTR-29
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
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 29mm navitor valve was implanted using a large flexnav delivery system (ds).The implant depth of the valve was 3mm at ncc and 4mm at lcc.The sizing of the annular dimensions of the native valve is: annulus diam 25.4mm, area 492.3, perimeter 79.5mm, and lvot diam 25.5mm.It was noted that there was adequate calcification to allow anchoring of the device and the aortic angle was 74 degrees.It was noted that the device migrated toward the aorta and a second 29mm navitor valve was implanted valve-in-valve to resolve the event.The procedure was able to be successfully completed.The physician doesn't believe the patient or user experienced adverse health consequences due to the performance of the product.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.The patient is stable.
Additional Manufacturer Narrative
The device was not returned for analysis.An event of migration 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 clinical engineering manager.Based on all available information, the reported migration appears to be related to challenging patient anatomy (horizontal aorta, large node of calcification).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 29mm navitor valve was implanted using a large flexnav delivery system (ds).The implant depth of the valve was 3mm at ncc and 4mm at lcc.The sizing of the annular dimensions of the native valve is: annulus diam 25.4mm, area 492.3, perimeter 79.5mm, and lvot diam 25.5mm.It was noted that there was adequate calcification to allow anchoring of the device and the aortic angle was 74 degrees.It was noted that the device migrated toward the aorta and a second 29mm navitor valve was implanted valve-in-valve to resolve the event.The procedure was able to be successfully completed.The physician doesn't believe the patient or user experienced adverse health consequences due to the performance of the product.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.The patient is stable.

• 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: 21792898
• Report Number: 2135147-2025-01829
• Device Sequence Number: 7789447
• Product Code: NPT
• UDI-Device Identifier: 05415067031600
• UDI-Public: (01)05415067031600(17)260621
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 05/29/2025

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: 06/21/2026
• Device Model Number: NVTR-29
• Device Catalogue Number: NVTR-29
• Device Lot Number: 9137631
• 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: 03/13/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2023
• 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: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female