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	Arrhythmia (1721); Heart Block (4444)
Date of Event	11/04/2025
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 29mm navitor vision valve was selected for implant using a unknown sized flexnav delivery system (ds).The patient had a prior medical history of aortic stenosis.The baseline rhythm was noted to be normal sinus rhythm.During the procedure, the valve was able to be implanted successfully at a depth of 1mm on the non-coronary cusp (ncc) and 4mm on the left-coronary cusp (lcc).Echocardiogram (echo) revealed a wide qrs complex but the patient still had the conduction.Later that night, the patient was implanted with a permanent pacemaker.The patient's status was stable.
Additional Manufacturer Narrative
An event of complete heart block was reported.A returned device assessment could not be performed as the device remains implanted and 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 cause of the reported incident could not be conclusively determined.The reported medical and surgical intervention are result of a temporary pacemaker and permanent pacemaker implants.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: health effect-clinical code: 1721.
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 a prior medical history of aortic stenosis and right bundle branch block (rbbb).There was no calcification extending beneath the aortic annular plane in the interventricular septum.The baseline rhythm was noted to be normal sinus rhythm.A pre-implant balloo aortic valvuloplasty (pre-bav) was performed using an unspecified balloon.The patient has developed with a complete heart block.During the procedure, the valve was able to be implanted successfully at a depth of 1mm on the non-coronary cusp (ncc) and 4mm on the left-coronary cusp (lcc).Echocardiogram (echo) revealed a wide qrs complex, but the patient still had the conduction.A temporary pacemaker was placed.The patient remained hemodynamically stable throughout the procedure, and there was no clinically significant delay reported.On the following day, the patient was implanted with a permanent pacemaker.The patient had an extended hospital stay for monitoring of rhythm.The patient's status was 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: 23662991
• Report Number: 2135147-2025-07027
• Device Sequence Number: 18749643
• Product Code: NPT
• UDI-Device Identifier: 05415067031600
• UDI-Public: (01)05415067031600(17)260327
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 03/04/2026

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: 03/27/2026
• Device Model Number: NVTR-29
• Device Catalogue Number: NVTR-29
• Device Lot Number: 8998075
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2023
• 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: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male