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

Model Number	NVRO-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	08/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 29mm navitor vision valve was selected for implant using a flexnav delivery system (ds).The patient has a severely calcified native valve, and aortic valve angle was measured to be 61 degrees.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed by using a 24mm, non-abbott balloon.During the procedure, ds was advanced through the transfemoral access and positioned in the native annulus as per the instructions for use (ifu).After achieving the desired implantation depth in cusp overlap view, an additional assessment was performed in left anterior oblique (lao) view to confirm central alignment of the ds.At 80 percent, the valve had appeared to be slightly deeper, and a partial recapture was performed.On the second attempt, the valve was positioned at a depth of approximately 4mm depth and confirmed in lao view with parallax eliminated.Post-deployment, immediately the valve had migrated into the left ventricular outflow tract (lvot).Two snares were used in an attempt to retrieve and reposition the valve.On both the occasions, the valve was successfully pulled back to an optimal position; however, it repeatedly migrated back into the lvot.During the third retrieval attempt, the valve dislodged into the ascending aorta and was subsequently left in place.A 25 mm sapien valve was then successfully implanted within the native valve.The patient remained hemodynamically stable throughout the procedure.Blood pressure was maintained, and no permanent pacemaker implantation was required.The patient is currently doing well.
Additional Manufacturer Narrative
The device remains 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.

• Brand Name: Navitor Vision
• 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: 50829364
• Report Number: 2135147-2026-06359
• Device Sequence Number: 8900320
• Product Code: NPT
• UDI-Device Identifier: 05415067045775
• UDI-Public: (01)05415067045775(17)290128
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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
• Report Date (Section B): 09/18/2026

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: NVRO-29
• Device Catalogue Number: NVRO-29
• Device Lot Number: 11265414
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2026
• 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: 84 YR
• Patient Sex: Male