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 Code	Insufficient Information (4580)
Date of Event	10/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 29mm navitor vision valve was selected for implant using an unknown delivery system (ds).The patient had prior medical history including sinus bradycardia (sb) and first-degree av block.During the procedure, the valve was reported to be implanted successfully.One week later on an unknown date, the patient returned to the hospital and received a permanent pacemaker.The physician doesn't believe the patient or user experienced adverse health consequences due to the performance of the product.The patient's status is unknown.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event for surgical intervention and hospitalization 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 information received, the effects on the patient were insufficiently described.The reported hospitalization and surgical intervention were the result of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2025, a 29mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).The patient had prior medical history including sinus bradycardia (sb) and first-degree av block.There was no calcification extending beneath the aortic annular plane in the interventricular septum.During the procedure, the valve was able to be implanted successfully at a depth of 4mm both on the non-coronary cusp (ncc) and left-coronary cusp (lcc).The patient remained hemodynamically stable throughout the procedure.Approximately one week later on an unknown date, the patient returned to the hospital for an unclear reason and received a permanent pacemaker.There was an initial or prolonged hospitalization due to the event.The physician doesn't believe the patient or user experienced adverse health consequences due to the performance of the product.The patient is stable.

• 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: 23442293
• Report Number: 2135147-2025-06317
• Device Sequence Number: 14626531
• Product Code: NPT
• UDI-Device Identifier: 05415067031600
• UDI-Public: (01)05415067031600(17)260205
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/24/2025

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: 02/05/2026
• Device Model Number: NVTR-29
• Device Catalogue Number: NVTR-29
• Device Lot Number: 8910309
• 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: 10/07/2025
• Supplement Date Received by Manufacturer: 11/09/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male