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

Model Number	NVRO-35
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Heart Block (4444)
Date of Event	08/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 35mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).The patient has a prior medical history of cardiac amyloidosis but no arrhythmias.The patient's aortic valve was measured to be 47 degrees.The length of the membranous septum was 6.8mm.There was calcification extending beneath the aortic annular plane in the interventricular septum.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed by using a 25mm, non-abbott balloon.Following pre-bav, the patient was developed with a heart block.During the procedure, at 80 percent, the valve was placed at a depth of 3-4mm then the valve was able to be implanted.Post-implant, heart block progressed to a complete heart block, and the patient was observed with asystole requiring chest compressions.A temporary pacemaker was placed to stabilize the cardiac rhythm, and the patient was also intubated.Medications were administered to treat the condition; after 3 minutes of chest compressions, the patient regained pulse.Ds was removed from the patient's anatomy, but the valve was observed to have migrated upwards; no paravalvular leak (pvl) was observed, and gradient was measured to be 5mmhg.The patient had an extended hospitalization.The implanter believes the cause of migration to be due to the chest compressions.The patient's condition is unknown.
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: 50531241
• Report Number: 2135147-2026-05941
• Device Sequence Number: 21373182
• Product Code: NPT
• UDI-Device Identifier: 05415067045768
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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-35
• Device Catalogue Number: NVRO-35
• Device Lot Number: 10637055
• 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: 08/10/2026
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 08/31/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2024
• 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: Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Unknown