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

Model Number	NVTR-23
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	09/24/2025
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 implanted in the patient using a small flexnav delivery system.The annular dimensions of the native valve were 313.53 mm² area, 64.4 mm perimeter.A pre-dilation performed with a non-abbott balloon.The final implant depth was 5mm.During the final evaluation of the valve implantation, a mild central leak was observed.A transesophageal echocardiogram (tee) was performed to confirm the finding.A post-implant balloon aortic valvuloplasty (bav) performed with a non-abbott balloon.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of mild central leak was observed during final implant 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.Imaging provided appeared to show the regurgitant jet was biased to one side of the valve rather than centralized, which may suggest a deployment or positioning issue, such as under expansion of the valve.However, this is speculation and cannot be confirmed as procedural imaging was not provided.Based on all available information, the cause for the reported central regurgitation could not be conclusively determined.Potentially, due to procedural circumstances.However, this cannot be conclusively determined.The reported unexpected medical intervention was a result of case-specific circumstances as post-implant valvuloplasty was performed.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: 23497990
• Report Number: 2135147-2025-06463
• Device Sequence Number: 8965737
• Product Code: NPT
• UDI-Device Identifier: 05415067031570
• UDI-Public: (01)05415067031570(17)261015
• 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): 12/12/2025

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 Model Number: NVTR-23
• Device Catalogue Number: NVTR-23
• Device Lot Number: 10064198
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2023
• 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
• Patient Age: 78 YR
• Patient Sex: Unknown