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

Model Number	NVTR-29
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation; the device was reportedly discarded.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 chosen for a procedure.During fluoroscopic inspection, the team observed that the stent was asymmetrical, which made it impossible to deploy the prosthesis.A new valve was chosen and completed the procedure.There were no consequences for the patient.The patient was reported stable.
Additional Manufacturer Narrative
It was reported that during fluoroscopic inspection the stent was observed asymmetrical making it impossible to deploy the prosthesis.A returned device inspection, to rule out any device-related causes, 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 limited information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 22336536
• Report Number: 2135147-2025-03434
• Device Sequence Number: 18375321
• Product Code: NPT
• UDI-Device Identifier: 05415067031600
• UDI-Public: (01)05415067031600(17)261008
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/18/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: NVTR-29
• Device Catalogue Number: NVTR-29
• Device Lot Number: 10053357
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2023
• 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
• Patient Sex: Unknown