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

Model Number	NVRO-23
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Incomplete Coaptation (2507); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	08/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 23mm navitor vision valve was selected for implant using a small flexnav delivery system (ds).Pre-implant balloon aortic valvuloplasty (pre-bav) was performed by using a 20mm, non-abbott balloon.During the procedure, an incomplete stent opening (iso) was observed but able to be mitigated as per the established steps.The valve was able to be implanted successfully without complications at a depth of 3mm on the non-coronary cusp (ncc).Post-implant, mild paravalvular leak (pvl) was noted.Post-implant balloon aortic valvuloplasty (post-bav) was performed by using a 23mm, non-abbott balloon with an additional 2ml inflation to optimize prosthesis expansion and correct the pvl.Post-procedure, transthoracic echocardiographic (tte) evaluation showed significant central aortic regurgitation, confirming prosthetic valve dysfunction with reported leaflet inactivity and hemodynamic instability characterized by alternating hypertension and hypotension.A second 23mm, navitor vision valve was implanted within the index valve.Final echocardiogram assessment showed absence of central regurgitation and pvl.No clinically significant delay occurred, no prolonged hospitalization was required, and the patient was 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: 50887932
• Report Number: 2135147-2026-06473
• Device Sequence Number: 18598594
• Product Code: NPT
• UDI-Device Identifier: 05415067045805
• 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
• Report Date (Section B): 09/24/2026

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-23
• Device Catalogue Number: NVRO-23
• Device Lot Number: 11199206
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2025
• 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: Female