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

Model Number	NVTR-29
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
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 29 mm navitor valve was chosen for implant using a large flexnav delivery system.During procedure, at 80% the valve seems to be at normal implant depth but at the final release, the valve experienced a migration towards aorta.The aorta was an horizontal one.The valve seems to be released into the annulus but slowly move up after the releasing.An additional non-abbott valve was implanted.The migrated valve was snared to bring stability to the second implanted valve.The snared valve was not repositioned.The patient experienced no coronary artery occlusion.The physician mentioned the cause of migration was horizontal aorta.The patient was reported stable.
Event or Problem Description
It was reported that on (b)(6) 2025, a 29mm navitor valve was chosen for implant using a large flexnav delivery system.During procedure, at 80% the valve seems to be at normal implant depth but at the final release, the valve experienced a migration towards aorta.The aorta was an horizontal one.The valve seems to be released into the annulus but slowly move up after the releasing.An additional non-abbott valve was implanted.The migrated valve was snared to bring stability to the second implanted valve.The snared valve was not repositioned.The patient experienced no coronary artery occlusion.The physician mentioned the cause of migration was horizontal aorta.The patient was reported stable.
Additional Manufacturer Narrative
An event of the valve migrating after implant was reported.It was indicated that the valve was released experienced a migration towards aorta.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 available information, the cause of the reported valve migration could not be conclusively determined.It is possible patient or procedural condition contributed to the reported event.However, this cannot be confirmed.The reported unexpected medical intervention and surgical intervention were a result of case-specific circumstances as snaring of device and another valve was implanted (valve-in-valve).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: 21950276
• Report Number: 2135147-2025-02325
• Device Sequence Number: 8548039
• Product Code: NPT
• UDI-Device Identifier: 05415067031600
• UDI-Public: (01)05415067031600(17)261015
• 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): 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 Model Number: NVTR-29
• Device Catalogue Number: NVTR-29
• Device Lot Number: 10066003
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LARGE FLEXNAV DELIVERY SYSTEM, FNAV-DS-LG, LOT NUM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown