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

Model Number	NVRO-27
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Tachycardia (2095); Ventricular Fibrillation (2130); Heart Failure/Congestive Heart Failure (4446)
Date of Event	02/13/2026
Type of Reportable Event	Death
Event or Problem Description
This complaint consists of tht registry data from japan.The information was obtained through the registry, no further details have become available for this event.It was reported through the tht registry from japan that on (b)(6) 2026, a 27mm navitor vision valve was implanted.Following discharge, the baseline functional status was approximately nyha class iii.Following an outpatient visit on (b)(6) 2026, the patient experienced shortness of breath and worsening heart failure.The patient then transferred hospital the following day.The heart failure exacerbation was considered mild.Congestion was not significant, elevated bnp levels and pleural effusion were observed.Human atrial natriuretic peptide (hanp) therapy was initiated for treatment.Additional diuretics were administered, resulting in improvement.Heart failure remained stable without oxygen support.On (b)(6) 2026, ventricular tachycardia and ventricular fibrillation occurred.Resuscitation was performed without success.The patient passed away on the same day.
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: 50620273
• Report Number: 2135147-2026-06044
• Device Sequence Number: 10697485
• Product Code: NPT
• UDI-Device Identifier: 05415067045799
• UDI-Public: (01)05415067045799(17)281005
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2026

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-27
• Device Catalogue Number: NVRO-27
• Device Lot Number: 11073161
• 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: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2025
• 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: Death; Hospitalization; Other; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male