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

Model Number	NVRO-27
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271); Transvalvular Pressure Gradient Increased (4854)
Date of Event	08/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 27mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).Pre-implant balloon aortic valvuloplasty (pre-bav) was performed by using a 22mm, non-abbott balloon.During the procedure, the valve was able to be deployed without a recapture at a depth of 5mm on the non-coronary cusp (ncc).Post-procedure peak to peak gradient was measured to be 11mmhg.Post-implant balloon aortic valvuloplasty (post-bav) was performed by using a 24mm, non-abbott balloon.During the closure process, the patient was developed with a localized pericardial effusion; cardiac tamponade and a pericardiocentesis (pericardial drainage) was performed to resolve the event.The patient's hemodynamic observed to have improved.No further bleeding was observed through the pericardial drainage procedure.At the end of procedure, the patient became hemodynamically stable.Post-procedure on the same day, the patient's condition was deteriorated and became unstable.The valve was explanted and replaced with an unspecified surgical valve.During the surgical procedure, it was identified that the cause to be due to the annular rupture.It was also commented that the contributing factors could be possibly due to a combination of the severity of leaflet calcification and the post-bav.The patient had an extended hospitalization and currently in a stable condition.
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.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: 50888256
• Report Number: 2135147-2026-06475
• Device Sequence Number: 10704943
• Product Code: NPT
• UDI-Device Identifier: 05415067045799
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted 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-27
• Device Catalogue Number: NVRO-27
• Device Lot Number: 11117656
• 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: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2025
• 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; Hospitalization
• Patient Sex: Unknown