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

Model Number	NVTR-25
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	05/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on 20 may 2025, a 25mm navitor valve was chosen for implant using a small flexnav delivery system.The patient's aortic valve angle (av angle from 3mensio) was 69 ° and the annulus diameter 18.5x26mm, area 371mm², perimeter 69mm, left ventricular outflow tract (lvot) 67.8 mm perimeter.During procedure, a pre-dilation was performed with a 20 mm balloon and the valve was implanted and deployed at a safe level of estimated 4-5mm.The retainer tabs were released, upon removal of the delivery system the valve moved into the ascending aorta.There was entanglement with the delivery system (ds) and navitor while removal of the ds after final deployment.The valve was pulled upward using a snare system and a new 23mm non-abbott valve was successfully implanted.After implantation, the patient had no coronary occlusion, no perivalvular leak (pvl), and no aortic regurgitation.The physician mentioned the cause of migration was a retainer tab was not fully released.There was no delay in the procedure and the patient remained hemodynamically stable throughout the procedure.The patient was reported stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of valve migration, and improper or incorrect procedure or method were reported.A returned device assessment could not be performed as the device was not returned for analysis.It was indicated that the cause of migration was a retainer tab was not fully released.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Abbott recommends to confirm that all 3 tabs are released, using multiple views if necessary, before removing the delivery system.Additionally if one tab is not yet released, abbott recommends specific mitigation techniques to release the tab.From received imaging these recommendations were not followed in this case, which contributed to the valve migration.Based on the available information, the cause of the reported migration could not be conclusively determined.It is possible that patient and procedural conditions, such as "little calcium" and implanting difficulties, contributed to the reported event; however, this cannot be confirmed.The reported improper or incorrect procedure or method was due to snaring the valve post-implant.The reported unexpected medical intervention and surgical intervention were result of case-specific circumstances: initially, as valve snared and a valve-in-valve procedure was performed.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note the per the instruction for use (ifu), ¿post-implantation precautions: once the valve is fully deployed, repositioning and retrieval of the valve is not possible.Attempted retrieval (e.G., use of a guidewire, snare, or forceps) may cause aortic root, coronary artery, and/or myocardial damage.¿ since the ifu deviation was performed to prevent an adverse patient effect and there is no indication that the deviation caused any patient harm, a letter will not be sent.

• 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: 22197969
• Report Number: 2135147-2025-03144
• Device Sequence Number: 8738177
• Product Code: NPT
• UDI-Device Identifier: 05415067031587
• UDI-Public: (01)05415067031587(17)270402
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 07/27/2025

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-25
• Device Catalogue Number: NVTR-25
• Device Lot Number: 10307867
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2024
• 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 Age: 86 YR
• Patient Sex: Female