MAUDE Adverse Event Report: Abbott Medical Navitor Transcatheter Aortic Valve; Aortic Valve, Prosthesis, Percutaneously Delivered

Model Number	NVTR-27
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 27mm navitor valve was selected for implant using a flexnav delivery system (ds).The patient's aortic valve angle was 41 degrees.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed by using a 20mm, non-abbott balloon.During the procedure, at 80 percent, the valve was placed at a depth of 3mm then the valve was able to be implanted.Upon removal of the ds, nosecone was observed to be entangled with the valve resulting in migration towards the aorta.A second 27mm, navitor valve was implanted inside the index valve to resolve the event.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported.The implanter believed the cause of migration to be due to the nose cone entanglement.The patient was reportedly discharged.
Event or Problem Description
It was reported that on (b)(6) 2026, a 27mm navitor valve was selected for implant using a flexnav delivery system (ds).The patient's aortic valve angle was 41 degrees.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed by using a 20mm, non-abbott balloon.During the procedure, at 80 percent, the valve was placed at a depth of 3mm then the valve was able to be implanted.Upon removal of the ds, nosecone was observed to be entangled with the valve resulting in migration towards the aorta.A second 27mm, navitor valve was implanted inside the index valve to resolve the event.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported.The implanter believed the cause of migration to be due to the nose cone entanglement.The patient was reportedly discharged.
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 valve migrating after implant 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.The cause of the reported migration appears to be the unintentional interaction between the valve and nosecone, but the cause of this interaction could not be conclusively 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 ; +1(651)756-5400
• MDR Report Key: 50098368
• Report Number: 2135147-2026-05215
• Device Sequence Number: 10368761
• Product Code: NPT
• UDI-Device Identifier: 05415067031594
• UDI-Public: (01)05415067031594(17)270807
• 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: 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): 10/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NVTR-27
• Device Catalogue Number: NVTR-27
• Device Lot Number: 10490949
• 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: 07/08/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2024
• 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 Sex: Unknown