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

Model Number	NVTR-25
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Dyspnea (1816); Heart Block (4444); Heart Failure/Congestive Heart Failure (4446)
Date of Event	11/01/2024
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) 2024, a 25mm navitor valve was implanted for transcatheter aortic valve implantation (tavi) procedure.The annular dimensions of the native valve were perimeter: 68.5 mm, minimum diameter: 19.4 mm, maximum diameter: 21.5 mm.The procedure was successful and the valve was implanted at a depth of 3mm.After the procedure, the patient developed complete atrioventricular block (av) block after the procedure and a permanent pacemaker was implanted during the same hospitalization.On (b)(6) 2025, the patient hospitalized with symptoms of dyspnea and decompensated heart failure, profile b.A transthoracic and transesophageal cardiac echocardiogram and confirmed thickened prosthetic leaflets with thrombus and vegetation.The patient was in current management includes outpatient clinical follow-up with anticoagulation and a return in 3 months for a new echocardiogram.
Additional Manufacturer Narrative
An event of complete atrioventricular block, dyspnea, decompensated heart failure, and thickened prosthetic leaflets with thrombus 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 available information, the cause of the reported complete atrioventricular block, dyspnea, decompensated heart failure, and thickened prosthetic leaflets with thrombus could not be conclusively determined.The reported hospitalization, surgical and unexpected medical intervention were results of case-specific circumstances as permanent pacemaker was implanted due to complete atrioventricular block and medication was administered due to the thrombus.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: 22977034
• Report Number: 2135147-2025-04987
• Device Sequence Number: 8972659
• Product Code: NPT
• UDI-Device Identifier: 05415067031587
• UDI-Public: (01)05415067031587(17)260528
• 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: 2024
• 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): 11/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2026
• Device Model Number: NVTR-25
• Device Catalogue Number: NVTR-25
• Device Lot Number: 9106860
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2023
• 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; Other
• Patient Age: 76 YR
• Patient Sex: Female