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

Model Number	NVTR-25
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
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 valve was selected for implant.Prior to procedure, the patient was "fine to do the procedure." the valve was implanted successfully and the patient was reported to do "well immediately after the procedure." on (b)(6) 2025, the patient reportedly became ill and "experienced clinical complications" and passed away.
Additional Manufacturer Narrative
An event of patient death was reported.A returned device assessment could not be performed as the device was not returned 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 available information, the cause of the reported incidents could not be conclusively determined.This appears to be a procedural mortality potentially related to airway injury following endotracheal intubation.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: health effect- impact code: 1802.Medical device problem code: 2993.
Event or Problem Description
It was reported that on (b)(6) 2025, a 25mm navitor valve was selected for implant.Patient comorbidities included hypertension, stenosis, and dyspnea.Prior to procedure, the patient was "fine to do the procedure." the annular dimensions was noted as sinotubular junction (sov): 31.1 mm, aortic annulus (ao): 34.2 mm, and left ventricular outflow tract (lvot): 21.9 mm.Predilatation was performed with an 18mm non-abbott balloon.The final implant depth of the valve was 4mm.There were no difficulties with deployment and/or retraction.The valve was implanted successfully and the patient was reported to do "well immediately after the procedure." no post-implant balloon valvuloplasty was performed.While in the intensive care unit (icu), the patient had complications related to airway bleeding and hypoxia.On (b)(6) 2025, the patient reportedly became ill and "experienced clinical complications" and passed away.

• 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: 22833889
• Report Number: 2135147-2025-04623
• Device Sequence Number: 9523127
• Product Code: NPT
• UDI-Device Identifier: 05415067031587
• UDI-Public: (01)05415067031587(17)260220
• 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: 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): 01/07/2026

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 Expiration Date: 02/20/2026
• Device Model Number: NVTR-25
• Device Catalogue Number: NVTR-25
• Device Lot Number: 8938851
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2023
• 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 Sex: Female