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

Model Number	NVTR-29
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Perivalvular Leak (1457); Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Vascular Dissection (3160); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	04/10/2025
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 valve was chosen for implant using a large flexnav delivery system.The annular dimensions of the native valve were perimeter 79mm and average diameter 24.8mm.During procedure, the valve was implanted too low and raised with 2 lasso and unfortunately migrated up in the sinus of valsalva (sov).At 80%, the implant depth was 2mm in left coronary cusp and 5mm in non-coronary cusp.The implant depth prior to migration was 4/5 mm.After the procedure an aortic regurgitation (ar) was noted.A 29mm non-abbott valve was implanted to correct the ar.After the procedure, the patient dissected the aorta and had to be operated on in cardiac surgery of a bentall.
Additional Manufacturer Narrative
An event of valve migration, perivalvular leak (pvl), vascular dissection, improper or incorrect procedure or method 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 available information, the cause of the reported aortic valve regurgitation appears to be a cascading effect of the device migration.However, the cause of the reported migration could not be conclusively determined.The reported aortic dissection appears to be related to procedural conditions, possibly due to migration or the snaring of the migrated valve.The reported improper or incorrect procedure or method was due to snaring the valve post-implant.The reported surgical intervention was a result of case-specific circumstances: initially, a valve-in-valve procedure was performed, followed by aortic root replacement surgery due to the aortic dissection.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note the per the instruction for use (ifu), ¿post-implantation precautions: once the valve is fully deployed, repositioning and retrieval of the valve is not possible.Attempted retrieval (e.G., use of a guidewire, snare, or forceps) may cause aortic root, coronary artery, and/or myocardial damage.Codes removed: medical device problem code: 1457 perivalvular leak.
Event or Problem Description
N/a.

• 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: 21960386
• Report Number: 2135147-2025-02356
• Device Sequence Number: 7265702
• Product Code: NPT
• UDI-Device Identifier: 05415067031600
• UDI-Public: (01)05415067031600(17)260604
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/12/2025

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: 06/04/2026
• Device Model Number: NVTR-29
• Device Catalogue Number: NVTR-29
• Device Lot Number: 9119020
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2023
• 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 Sex: Unknown