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

Model Number	NVRO-27
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Stroke/CVA (1770); Cognitive Changes (2551); Vascular Dissection (3160); Movement Disorder (4412)
Date of Event	08/26/2026
Type of Reportable Event	Death
Event or Problem Description
(b)(4), patient site id: (b)(6).It was reported that on (b)(6) 2026, a 27mm navitor with radiopaque markers was chosen for implant.Prior to procedure, patient's condition was reported stable.Post-procedure, it was reported patient experienced amnesia, persistent severe motor restlessness, and speech disorder.Neurology was consulted and computed tomography (ct) was performed on (b)(6) 2026.Findings concluded delineation of subacute infarct adjacent to pre-existing cortico-subcortical parenchymal defect in the left frontal region.Stroke symptoms lasted weeks.It was later reported on (b)(6) 2026, a type a dissection was noted via transesophageal echocardiogram (tee) extending into the right iliac arteries and common carotid artery with renal arteries originating from the true lumen.A ct confirmed type a aortic dissection, starting from the distal to the sino-tubular junction, extending proximally into the left anterior interior chain (aic), with extension into the brachiocephalic trunk and right carotids.Patient was administered medication.The physician attributed the cause of the type a dissection due to the navitor valve.Patient was reported to have passed away on (b)(6) 2026.The cause of death was reported sudden death with probable type a dissection.
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: 50940679
• Report Number: 2135147-2026-06609
• Device Sequence Number: 10759557
• Product Code: NPT
• UDI-Device Identifier: 05415067045799
• UDI-Public: (01)05415067045799(17)290329
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 11401392
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2026
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 176 LB