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); Perivalvular Leak (1457); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	03/13/2025
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 29mm navitor valve was selected for implant using a large flexnav delivery system.A pre-dilation was performed using a 21mm non-abbott device.It was noted during procedure, that the valve migrated toward the left ventricle upon final deployment.The valve was re-sheathed once during procedure.At 80% and at final deployment, the implant depth of the valve was at 4mm.Prior to final deployment the delivery system was in neutral position/to slight forward pressure.The guidewire was pulled to a midventricular position to deflect nosecone and two different views were used to confirm all 3 retainers tabs had released.The patient's aortic valve angle was 41 degrees.The migrated valve did not block a coronary artery or arteries.There was no entanglement with the delivery system and valve while removing the delivery system after final deployment.Post-implant, a supraskirtal leak was also noted.There was sufficient calcium to allow anchoring of the valve.The decision was made to attempt snaring of the valve.A second 27mm navitor valve was implanted in a valve-in-valve procedure to stop aortic regurgitation.There was no initial or prolonged hospitalization due to this event.There was no issue/malfunction or adverse event related to the large flexnav delivery system.The cause of migration of the 29mm navitor is attributed to aortic regurgitation.The patient was recovering at the time of report.
Additional Manufacturer Narrative
The device was not returned for analysis.An event of migration, perivalvular leak (pvl), improper or incorrect procedure or method, and aortic regurgitation was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on all available information, the reported pvl is a cascading event of the migration.The reported migration is a cascading event of the aortic regurgitation, per case details.A cause for the reported aortic regurgitation could not be conclusively determined.The reported improper or incorrect procedure or method is related to the user attempting to snare the device.The reported unexpected medical intervention and surgery were the results of case-specific circumstances.It should be noted that the navitor¿ transcatheter aortic valve implantation system instructions for use (ifu), post-implantation precautions, states, "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." in this case, the device was attempted to be snared after deployment.This deviation from the ifu did not appear to cause or contribute to any issues.Therefore, a letter will not be sent to address the deviation.

• Brand Name: NAVITOR TRANSCATHETER AORTIC VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21792585
• Report Number: 2135147-2025-01828
• Device Sequence Number: 7844366
• Product Code: NPT
• UDI-Device Identifier: 05415067031600
• UDI-Public: (01)05415067031600(17)261106
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 04/24/2025

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: 10103835
• 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: 04/15/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2023
• 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 DS, FNAV-DS-LG (LOT: 10463950)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 55 KG