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); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 23 mm navitor valve was chosen for a valve in valve procedure.A 21 mm non-abbott valve was implanted in 2021.The patient's aortic valve angle (av angle from 3mensio) was 48.Due to aortic insufficiency, the patient underwent a valve-in-valve aortic valve replacement with a 23 mm navitor valve.A pre-implant balloon valvuloplasty done with a 20 mm non-abbott balloon and which was successful.After the release the valve migrated into aorta.At 80%, the implant depth was 6 mm and the implant depth at release prior to migration was 6 mm.The navitor valve was implanted in a good position.After implantation, the prosthesis began to embolize, gradually migrating upward.A post dilatation was performed with a 20 mm balloon to better anchor the prosthesis, which initially stabilized but then migrated slightly further.A new 23 mm navitor valve was chosen for implant.Before implanting the second valve, cracking was performed using 20 mm non-abbott balloon, followed by successful implantation of a second navitor 23.There was zero leak and a gradient of 7 mmhg.The patient left the procedure room in good condition.
Additional Manufacturer Narrative
An event of off-label use and valve migration 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 available information, the cause of the reported valve migration could not be conclusively determined.The off-label use was due to a valve-in-valve procedure.The reported surgical and unexpected intervention were results of case-specific circumstances as post-bav was performed in attempt to stabilize the migrated valve and subsequently 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.It should be noted that per the instruction for use, ¿contraindications: the valve is contraindicated for patients with any leaflet configuration other than tricuspid.¿.
Event or Problem Description
N/a.

• 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: 23285958
• Report Number: 2135147-2025-05822
• Device Sequence Number: 8956439
• Product Code: NPT
• UDI-Device Identifier: 05415067031570
• UDI-Public: (01)05415067031570(17)260924
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 12/12/2025

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: 09/24/2026
• Device Model Number: NVTR-23
• Device Catalogue Number: NVTR-23
• Device Lot Number: 10036038
• 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: 09/18/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2023
• 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