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

Model Number	NVTR-29
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on 18 july 2025 a 29mm navitor transcatheter aortic valve was selected for implant using a large flexnav delivery system.The patient's annulus was measured with a perimeter of 26.2mm.The patient's thoracic aorta was kinked.The initial implant depth was 5mm from the non-coronary cusp (ncc) and 3mm from the left coronary cusp (lcc).The decision was made to place the valve deeper toward the left ventricular outflow tract (lvot).The final implant depth was 6mm from the ncc and 5mm from the lcc.During detachment of the third retainer tab, the valve moved to the ncc side and rested at 0mm intra-annular.The patient remained hemodynamically stable throughout the procedure.The patient did not present with any clinical signs or symptoms.The patient status was stable.
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.
Additional Manufacturer Narrative
An event of the device migration was reported.It was indicated that the patient remained hemodynamically stable throughout the procedure.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported on 18 july 2025, a 29mm navitor transcatheter aortic valve was selected for implant using a large flexnav delivery system.The patient's annulus was measured with a perimeter of 26.2mm.The patient's thoracic aorta was kinked.The initial implant depth was 5mm from the non-coronary cusp (ncc) and 3mm from the left coronary cusp (lcc).The decision was made to place the valve deeper toward the left ventricular outflow tract (lvot).The final implant depth was 6mm from the ncc and 5mm from the lcc.During detachment of the third retainer tab, the valve moved to the ncc side and rested at 0mm intra-annular.The patient remained hemodynamically stable throughout the procedure.The patient did not present with any clinical signs or symptoms.The patient status was stable.

• 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: 22784322
• Report Number: 2135147-2025-04470
• Device Sequence Number: 9822937
• Product Code: NPT
• UDI-Device Identifier: 05415067031600
• UDI-Public: (01)05415067031600(17)250824
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/16/2025

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: 08/24/2025
• Device Model Number: NVTR-29
• Device Catalogue Number: NVTR-29
• Device Lot Number: 8661263
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2022
• 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: LARGE FLEXNAV DS [FNAV-DS-LG, LOT: 10685900].
• Patient Age: 89 YR
• Patient Sex: Female