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

Model Number	NVRO-29
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Perivalvular Leak (1457); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	07/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 29 mm navitor vision valve was selected for implant using a large flexnav delivery system.The annular dimensions were reported as an annulus perimeter-derived diameter of 26.8 mm and an lvot diameter of 26.2 mm.It was reported that there was sufficient calcium to allow anchoring of the device.During the procedure, pre-dilation was performed using a 24 mm non-abbott balloon.The valve was recaptured more than two times because the implant position was considered too deep.Prior to final deployment, the implanter ensured that the delivery system was in a neutral position to slight forward pressure and pulled the guidewire to a mid-ventricular position to deflect the nose cone.The reported fluoroscopic projections were lao 9/cranial 4 and cusp overlap rao 17/caudal 19.At approximately 80% deployment, the implant depth was reported as 3 mm at the non-coronary cusp (ncc) and 4 mm at the left coronary cusp (lcc).The implanter confirmed that all three tabs had successfully released using two different views.The implant depth at release was reported as 3 mm at the ncc and 4 mm at the lcc.Following correct initial positioning and final release, the valve slipped deeper toward the left ventricular outflow tract (lvot).The delivery system remained within the patient's anatomy at the time the migration occurred.Angiography revealed a moderate paravalvular leak.The physicians decided to reposition the valve superiorly using two snares.The repositioning maneuver was successful, resulting in a final position of 3 mm at the non-coronary cusp (ncc) and 3¿4 mm at the left coronary cusp (lcc).The migrated valve did not obstruct any coronary artery.No entanglement between the delivery system and the navitor valve was reported during removal of the delivery system after final deployment.No post-dilatation was performed.The implanter did not provide a cause for the migration.No paravalvular leak was observed following repositioning.The patient remained hemodynamically stable throughout the procedure.No clinically significant delay was reported.No initial or prolonged hospitalization due to the event was reported.The healthcare professional did not believe the patient experienced adverse health consequences due to the performance of the product.The patient's status was reported as stable.
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: 50305563
• Report Number: 2135147-2026-05662
• Device Sequence Number: 21393961
• Product Code: NPT
• UDI-Device Identifier: 05415067045775
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 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-29
• Device Catalogue Number: NVRO-29
• Device Lot Number: 11428986
• 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: 07/24/2026
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 08/18/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FlexNav, FNAV-DS-LG.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown