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

Model Number	NVTR-25
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 25mm navitor vision was chosen implantation, utilizing an unknown flexnav.After pre-dilation with a 20mm balloon, the first deployment attempt was rated at 80%.However, the valve was positioned too low.The implanted attempted three further positioning attempts, but the valve consistently descended too deep into the left ventricular outflow tract (lvot).A final positioning attempt was made, and the valve was at a depth of approximately 3-4mm of non coronary cusp (ncc) and 6-7mm on the left coronary cusp (lcc).A decision was made to deploy the valve.However, after full deployment, the valve migrated deeper into the lvot, leading to aortic regurgitation.Attempts to position the valve higher utilizing a snare were unsuccessful, and aortic regurgitation persisted.A decision was made to implant a 23mm edwards valve, which was successfully deployed.After implantation, the patient had no coronary occlusion, no paravalvular leak (pvl), and no aortic regurgitation.The patient was reported to be stable.
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
Subsequent to the previously filed report, additional information was received: the native valve had the following sizing: annulus diameter 18x26 mm, area 343mm², perimeter 69mm, lvot per.69.1.It was noted that there was sufficient calcium to allow anchoring of the device.Pre-dilation was performed with a 20mm simvalve balloon and min annulus was 18mm.During prep for final deployment, it was ensured that the delivery system (ds) was in neutral position/to slight forward pressure, and the guidewire was pulled to a midventricular position to deflect the nosecone.Upon deployment, all three tabs were confirmed to be successfully released using two different views.The valve was implanted at a depth at 80% was estimated at approximately 5-6mm.The device migrated toward the ventricle immediately and was too deep in the left ventricle (lv) at a depth of 20mm.An attempt was made to snare the device to a higher position but was not successful.A second transcatheter, a 23mm s3, was required for treatment, and a second valve was implanted inside the index valve.It was noted that the migrated valve did not block any coronary artery or arteries.Post dilation was not performed.In the physician¿s opinion, the cause of migration was due to the size of the valve; a larger valve should have been used for treatment.
Additional Manufacturer Narrative
It was reported that the navitor device migrated deeper into the lvot after full deployment leading to aortic regurgitation.Information from field indicated that the valve was positioned too low; three further positioning attempt were made, but the valve consistently descended too deep into the lvot.The device remains implanted and will not return to abbott 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 information received, the cause of the reported device migration appears to be related to procedural difficulties (device positioning).However, this could not be confirmed.Information from field indicated that the cause of migration was due to the device sizing.The reported unexpected medical intervention and surgical intervention were the results of case-specific circumstances, as an unsuccessful attempt was made to snare the migrated valve to a higher position, and a second transcatheter a was required for treatment.A second valve was implanted inside the index valve.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note that per the instructions for use, "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." and "implantation precautions: do not re-sheath the valve more than two times prior to final valve release.Additional re-sheath attempts may compromise product performance.".

• 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: 22171584
• Report Number: 2135147-2025-03067
• Device Sequence Number: 9218462
• 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): 07/25/2025

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: 05/15/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/25/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FLEXNAV DELIVERY SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female