MAUDE Adverse Event Report: ABBOTT MEDICAL Navitor Vision; Aortic Valve, Prosthesis, Percutaneously Delivered

Model Number	NVRO-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/10/2026
Type of Reportable Event	Death
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.
Event or Problem Description
It was reported that on (b)(6) 2026, a 23 mm navitor vision valve was selected for implant using a flexnav delivery system (ds).During the procedure, the valve was able to be implanted.Post-procedure one month later, the patient started showing symptoms of a staphylococcal infection, which was subsequently confirmed to be present around the aortic, mitral, and tricuspid valves.Medication was administered and an open-heart surgery were performed as an intervention to treat the event.The patient also had an extended hospitalization.On an unknown date, the patient passed away.The cause of death were infections.The implanter classified this event as being related to the procedure and patient¿s past medical history.
Event or Problem Description
It was reported that on (b)(6) 2026, a 23mm navitor vision valve was selected for implant using a flexnav delivery system (ds).During the procedure, the valve was able to be implanted.Post-procedure one month later, the patient started showing symptoms of a staphylococcal infection, which was subsequently confirmed to be present around the aortic, mitral, and tricuspid valves.Medication was administered and an open-heart surgery were performed as an intervention to treat the event.The patient also had an extended hospitalization.On an unknown date, the patient passed away.The cause of death were infections.The implanter classified this event as being related to the procedure and patient¿s past medical history.
Additional Manufacturer Narrative
An event of an infection leading to hospitalization, surgical intervention, and death was reported.As the device was not returned to abbott for analysis, a returned device assessment could not be performed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the limited information provided and without the device to analyze, the cause of the reported infection and death could not be determined.The reported unexpected medical intervention and surgical intervention were results of case-specific circumstances as medication was administered and the patient underwent open-heart surgery.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 25692352
• Report Number: 2135147-2026-04619
• Device Sequence Number: 9669596
• Product Code: NPT
• UDI-Device Identifier: 05415067045805
• UDI-Public: (01)05415067045805(17)280409
• 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): 09/15/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: NVRO-23
• Device Catalogue Number: NVRO-23
• Device Lot Number: 10837712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 07/02/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2025
• 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: Hospitalization; Required Intervention; Death
• Patient Sex: Unknown