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

Model Number	NVTR-25
Medical Device Problem Codes	Material Deformation (2976); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
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 on (b)(6) 2025 a navitor valve was selected for implant using a small flexnav delivery system.The patient's aortic angle was 35 degrees.The devices were prepared per instructions for use (ifu).During the procedure, some resistance was noted when inserting the delivery system into the patient anatomy.While advancing the delivery system through the aortic arch, a fold was noted in the valve capsule of the delivery system.Subsequently an in-fold was noted on the valve when the delivery system was in the patient's ascending aorta.The valve and delivery system were removed from the patient for inspection.A kink was confirmed on the delivery system.An attempt was made to deploy the valve outside of the patient using the release wheel, however the valve was only able to be released at 50% even after fully rotating the wheel.A guidewire was used to straighten the delivery system.The valve was re-captured and re-opened by pulling the macro slide button backwards.The valve was able to be deployed and separated from the delivery system.The valve was re-used with a new small flexnav delivery system for successful implantation.The patient did not present with any clinical signs or symptoms.The patient status was stable.
Event or Problem Description
It was reported on (b)(6) 2025 a navitor valve was selected for implant using a small flexnav delivery system.The patient's aortic angle was 35 degrees.The devices were prepared per instructions for use (ifu).During the procedure, some resistance was noted when inserting the delivery system into the patient anatomy.While advancing the delivery system through the aortic arch, a fold was noted in the valve capsule of the delivery system.Subsequently an in-fold was noted on the valve when the delivery system was in the patient's ascending aorta.The valve and delivery system were removed from the patient for inspection.A kink was confirmed on the delivery system.An attempt was made to deploy the valve outside of the patient using the release wheel, however the valve was only able to be released at 50% even after fully rotating the wheel.A guidewire was used to straighten the delivery system.The valve was re-captured and re-opened by pulling the macro slide button backwards.The valve was able to be deployed and separated from the delivery system.The valve was re-used with a new small flexnav delivery system for successful implantation.The patient did not present with any clinical signs or symptoms.The patient status was stable.
Additional Manufacturer Narrative
It was reported that while advancing the delivery system a fold was noted in the valve capsule and an in-fold was noted on the valve when the delivery system was in the patient's ascending aorta.Also reported that the valve was attempted to be deployed outside the patient, however the valve was only able to be released at 50% even after fully rotating the wheel.The valve was deployed with a new flexnav delivery system.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 defined manufacturing specifications.Cine review performed at abbott showed no signs of valve infold.Based on the information received, the cause of the reported incident could not be determined.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: 22700716
• Report Number: 2135147-2025-04304
• Device Sequence Number: 18378891
• Product Code: NPT
• UDI-Device Identifier: 05415067031587
• UDI-Public: (01)05415067031587(17)260827
• 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): 09/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/27/2026
• Device Model Number: NVTR-25
• Device Catalogue Number: NVTR-25
• Device Lot Number: 9251129
• 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: 07/10/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 09/17/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 25MM NAVITOR VALVE [NVTR-25, SERIAL: (B)(6)]
• Patient Age: 83 YR
• Patient Sex: Female