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

Model Number	NVRO-27
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, a (b)(6) navitor vision valve was selected for implant using a flexnav delivery system (ds).The patient's aortic valve angle was measured to be (b)(6).Pre-implant balloon aortic valvuloplasty (pre-bav) was performed by using a (b)(6), non-abbott balloon.During the procedure, on the first attempt, at 80 percent, the valve was positioned at a depth of (b)(6) on the non-coronary cusp (ncc) and (b)(6) on the left-coronary cusp (lcc) based on the contrast injections in both the cusp overlap views and a left anterior oblique (lao) view with parallax removed from the valve frame.The decision was made to proceed with a slow release of the valve with controlled pacing at 120 beats per minute and a slow release of the first 2 retainer tabs, the valve remained in a stable and acceptable position.Upon release of the 3rd tab from the ds valve capsule the valve embolized up (aortic) above the annular plane along the non-coronary cusp (ncc) side of the native valve while remaining below the annular plane of left coronary cusp (lcc) in an acceptable position.The patient remained stable throughout this timeframe; transthoracic echocardiogram (tte) results showed no paravalvular leak (pvl) with a mean gradient of 5 mmhg.All catheters and introducers were removed from the patient, and vessel closure was achieved without further incident.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported.Post-procedure, later that day a follow-up bedside echocardiogram (echo) was obtained, and the patient remained stable with trace pvl and a gradient of 9 mmhg.The patient was in stable condition and subsequently 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.

• 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: 50863284
• Report Number: 2135147-2026-06421
• Device Sequence Number: 16124907
• Product Code: NPT
• UDI-Device Identifier: 05415067045799
• UDI-Public: (01)05415067045799(17)290125
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: NVRO-27
• Device Catalogue Number: NVRO-27
• Device Lot Number: 11262329
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2026
• 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
• Patient Age: 84 YR
• Patient Sex: Male