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

Model Number	NVTR-29
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130)
Date of Event	06/24/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2026, a 29mm navitor valve was chosen for implanted.The patient was unable to undergo the tavi procedure via the transfemoral approach due to the presence of an aortic aneurysm.It was decided to proceed with the procedure via the left trans-carotid approach.The valve was position and at approximately 80% of deployment, improper position was observed and the valve was recaptured.The deployment process was restarted with pacing at 120 bpm.During the valve deployment, the patient developed hemodynamic instability, progressing to hypotension and ventricular fibrillation.Therefore, the valve was recaptured and resuscitation maneuvers, including defibrillation, administration of epinephrine and chest compressions were performed without success.After the first resuscitation cycle, the patient was still in cardiac arrest, the valve was then deployed and resuscitation efforts continued.However, the patient progressed to asystole.On echocardiographic assessment, the valve was found to be in an appropriate position.After approximately 40 minutes of resuscitation efforts, the patient passed away.
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.

• 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: 25860435
• Report Number: 2135147-2026-04923
• Device Sequence Number: 14768946
• Product Code: NPT
• UDI-Device Identifier: 05415067031600
• UDI-Public: (01)05415067031600(17)261212
• 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: 2026
• 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
• Report Date (Section B): 07/17/2026

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 Model Number: NVTR-29
• Device Catalogue Number: NVTR-29
• Device Lot Number: 10143631
• 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: 06/24/2026
• Initial Report FDA Received Date: 07/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2023
• 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: Death
• Patient Age: 83 YR
• Patient Sex: Unknown