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

Model Number	NVTR-27
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
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) 2026, a 27mm, navitor valve was selected for implant using a large flexnav delivery system (ds).The patient has a horizontal anatomy with the valve measuring to 57 degrees.Aortic valve calcification was classified as severe.During the procedure, at 80 percent, the valve was seated at 3mm depth.After full deployment, one of the retainer tabs remained over the retainer receptacles and with the gentle movement from the guidewire, the valve popped up.The valve was pulled up over the coronary arteries using a snare and a second 27mm navitor valve was selected for implant using a large flexnav ds.The valve was able to be implanted successfully.The patient remained hemodynamically stable throughout the procedure, and there was no clinically significant delay reported.No additional information was provided.The implanter believes the cause of migration to be due to an operator error since just before confirming the release to the other view the second implanter pushed the guide wire by mistake and the valve popped up.The patient was in a discharged in a stable condition.
Additional Manufacturer Narrative
An event of device migration, difficult or delayed separation, and improper or incorrect procedure or method was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Information from the field indicated that after the valve was fully deployed, one of the retainer tabs remained over the retainer receptacles and with the gentle movement from the guidewire, the valve popped up, and the valve was attempted to be snared.The patient has a horizontal anatomy with the valve measuring to 57 degrees.Aortic valve calcification was classified as severe.The provided videos were reviewed by an abbott representative.Based on all available information, the reported migration appears to be related to procedural conditions (the valve popped up due to an operator error).The reported difficult or delayed separation is due to the retainer tab remained over the retainer receptacles.However, a cause for the retainer tab getting stuck could not be conclusively determined.It is possible that patient anatomy (57-degree aorta, and severe calcification) contributed to this issue.However, this cannot be confirmed.The reported improper or incorrect procedure or method is related to the user snaring the valve.

• 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: 24406319
• Report Number: 2135147-2026-01090
• Device Sequence Number: 9905655
• Product Code: NPT
• UDI-Device Identifier: 05415067031594
• UDI-Public: (01)05415067031594(17)270425
• 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: 2026
• 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): 04/09/2026

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-27
• Device Catalogue Number: NVTR-27
• Device Lot Number: 10342497
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2024
• 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: 77 YR
• Patient Sex: Male