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

Model Number	NVTR-23
Medical Device Problem Codes	Off-Label Use (1494); Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Heart Block (4444)
Date of Event	04/30/2025
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
Clinical information: (b)(4) vantage, patient site id: (b)(6).It was reported that on (b)(6) 2025, a 23mm navitor valve was successfully implanted in a patient within a 23mm non-abbott surgical valve.While in cusp overlap view and prior to deployment, the inflow edge of the constrained valve frame was aligned at the base of the non-coronary cusp.The valve was re-sheathed twice during procedure once for being deployed to low, and once too high.The final non-coronary cusp implant depth was 6.7mm.There was no calcification extending beneath the aortic annular plane in the interventricular septum.A post-implant balloon aortic valvuloplasty was performed using a 22mm non-abbott device, due to a high aortic valve gradient of 15mmhg noted by invasive pressure measurement.There was no clinically significant delay in procedure reported.On (b)(6) 2025, it was noted via electrocardiogram that the patient developed a complete heart block.On (b)(6) 2025, the decision was made to implant a permanent pacemaker.The cause of the patient's high aortic valve gradient is attributed to the non-perfect adherence of 23mm navitor valve into the 23mm non-abbott surgical valve.The patient was discharged at the time of report.
Additional Manufacturer Narrative
The device was not returned for analysis.An event of off-label use and device stenosis 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 off-label use is related to the device being used for a valve-in-valve procedure.Cause for the stenosis not be conclusively determined.It is possible that the off-label use or other procedural conditions, contribute the event.However, this cannot be confirmed.The reported unexpected medical intervention and surgery were the result of case-specific circumstances as permanent pacemaker was implanted.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.In this case, the device was selected for a valve-in-valve procedure.This case is included in a pre-market clinical study investigating the safety and efficacy of the navitor valve in a valve-in-valve procedure.Therefore, a letter will not be sent to address the deviation from the ifu.

• 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: 22114963
• Report Number: 2135147-2025-02862
• Device Sequence Number: 4251064
• Product Code: NPT
• UDI-Device Identifier: 05415067031570
• UDI-Public: (01)05415067031570(17)251113
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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 Expiration Date: 11/13/2025
• Device Model Number: NVTR-23
• Device Catalogue Number: NVTR-23
• Device Lot Number: 8785252
• 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: 05/05/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 75 KG