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

Model Number	NVTR-29
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	10/04/2025
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 large flexnav delivery system (ds).The patient had a prior medical history of severe aortic stenosis and aortic valve insufficiency.The annulus diameter, area, and perimeter of the native valve were measured to be 26.9mm, 556.1mm2, and 84.4mm respectively.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed using a 23mm non-abbott balloon.The valve was reported to be implanted at a depth of 9mm both on the non-coronary cusp (ncc) and left-coronary cusp (lcc).A post-implant balloon aortic valvuloplasty (post-bav) was performed using a 25mm non-abbott balloon.On (b)(6) 2025, the patient presented with severe perivalvular leak (pvl).A 29mm navitor vision valve was selected for implant using a large flexnav ds.During the procedure, a snare was used to assist the ds in crossing the prosthetic valve.The valve was implanted at a depth of 2mm both on the non-coronary cusp (ncc) and left-coronary cusp (lcc) resulting in mild pvl.The patient remained hemodynamically stable throughout the procedure, and there was no clinically significant delay reported.The physician doesn't believe the patient or user experienced adverse health consequences due to the performance of the product.The patient¿s status was stable.
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 severe aortic stenosis and aortic valve insufficiency.The annulus diameter, area, and perimeter of the native valve were measured to be 26.9mm, 556.1mm2, and 84.4mm respectively.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed using a 23mm non-abbott balloon.The valve was reported to be implanted at a depth of 9mm both on the non-coronary cusp (ncc) and left-coronary cusp (lcc).On (b)(6) 2025, severe perivalvular leak (pvl) was noted.A 29mm navitor vision valve was selected for an implant using an unknown sized flexnav ds.During the procedure, the ds was in contact with the first valve, and it was required to elevate the radiopaque tip in order to cross the second valve by the snare technique.The valve was implanted at a depth of 2mm both on the non-coronary cusp (ncc) and left-coronary cusp (lcc).No pvl noted with the gradient pressure of 8mmhg.The patient remained hemodynamically stable throughout the procedure, and there was no clinically significant delay reported.The hospitalization was prolonged due to this event.The physician doesn't believe the patient or user experienced adverse health consequences due to the performance of the product.The patient was discharged.
Additional Manufacturer Narrative
An event of perivalvular leak (pvl) 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 all available information, the reported pvl could not be conclusively determined.It is possible patient conditions.However, this cannot be confirmed.The reported regurgitation and hospitalization may represent cascade effects resulting from the reported pvl.The reported surgical intervention is the result of case-specific circumstances, as valve-in-valve was perfomed.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 23417489
• Report Number: 2135147-2025-06196
• Device Sequence Number: 9085208
• Product Code: NPT
• UDI-Device Identifier: 05415067031600
• UDI-Public: (01)05415067031600(17)260827
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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 Expiration Date: 08/27/2026
• Device Model Number: NVTR-29
• Device Catalogue Number: NVTR-29
• Device Lot Number: 9251131
• 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: 10/04/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2023
• 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: 86 YR
• Patient Sex: Male
• Patient Weight: 69 KG