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

Catalog Number	NVTR-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Embolism/Embolus (4438)
Date of Event	01/27/2025
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
It was reported that on (b)(6) 2025, a 23mm navitor valve was successfully implanted.On (b)(6) 2025, the patient had a stroke and a cyanotic finger suggesting embolic causes and arterial obstruction.There is no allegation that the patient experienced adverse health consequences due to the performance of the product.The physician alleges that the stroke was caused by the procedure and noted that the patient had calcified arteries.
Additional Manufacturer Narrative
The device was not returned for analysis.An event of stroke and embolism 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 stroke and embolism appear to be related to a combination of the implant procedure and patient condition (calcified arteries).There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.

• 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: 21479447
• Report Number: 2135147-2025-00977
• Device Sequence Number: 4121174
• Product Code: NPT
• UDI-Device Identifier: 05415067031570
• UDI-Public: (01)05415067031570(17)251211(10)8818960
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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: 12/11/2025
• Device Catalogue Number: NVTR-23
• Device Lot Number: 8818960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2022
• 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: Life Threatening; Disability; Other
• Patient Age: 84 YR
• Patient Sex: Female