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

Model Number	NVTR-25
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)
Date of Event	12/03/2025
Type of Reportable Event	Death
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
It was reported that on (b)(6) 2025, a 25mm navitor vision valve was selected for implant using a small flexnav delivery system (ds).The patient had a prior medical history of left ventricular ejection fraction 27%, severe tricuspid regurgitation, moderate mitral regurgitation and heart failure.Prior to procedure, the patient was in a critical condition.During the procedure, the valve was able to be implanted at a depth of 5mm on the non-coronary cusp (ncc).Post-implant, while removing the ds the patient developed cardiac arrest.Despite all resuscitation maneuvers the patient was deceased on the same day.
Event or Problem Description
It was reported that on (b)(6) 2025, a 25mm navitor vision valve was selected for implant using a small flexnav delivery system (ds).The patient had a prior medical history of left ventricular ejection fraction 27%, severe tricuspid regurgitation, moderate mitral regurgitation and heart failure.Prior to procedure, the patient was in a critical condition.During the procedure, the valve was able to be implanted at a depth of 5mm on the non-coronary cusp (ncc).Post-implant, while removing the ds the patient developed cardiac arrest.Despite all resuscitation maneuvers the patient was deceased on the same day.
Additional Manufacturer Narrative
An event for hypotension, cardiac arrest, and patient death was reported.A returned device assessment could not be performed as the device was not returned for analysis.Reportedly, the patient had prior medical history including left ventricular ejection fraction 27%, severe tricuspid regurgitation, moderate mitral regurgitation and heart failure.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, causes for the reported death, hypotension, and cardiac arrest could not be conclusively determined.It is possible that patient condition contributed to this event.However, this cannot be confirmed.The reported unexpected medical interventions were a result of case-specific circumstances as cpr was performed and medications were administered to address the hypotension.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.The event was reviewed by an abbott senior director of medical affairs: limited narrative was provided.The cause of death is most likely related to the patient¿s critical condition and underlying comorbidities.Should further information and/or imaging become available, an addendum will be issued to this review.

• 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: 23894366
• Report Number: 2135147-2025-07739
• Device Sequence Number: 20169458
• Product Code: NPT
• UDI-Device Identifier: 05415067031587
• UDI-Public: (01)05415067031587(17)280412
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 02/23/2026

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-25
• Device Catalogue Number: NVTR-25
• Device Lot Number: 10840157
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/25/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2025
• 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: Disability; Required Intervention; Death
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 62 KG