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

Model Number	NVRO-35
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	07/09/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2026, a 35mm navitor vision valve was chosen for implant using a large flexnav delivery system.The patient had a history of severe symptomatic aortic stenosis, a small pericardial effusion and bilateral pleural effusion was noted pre-procedure.The physician decided to perform a post-bav with a 26mm true balloon.However, the balloon was unable to be withdrawn into the 14fr sheath after multiple attempts.While preparing to remove the balloon and sheath through the arteriotomy, there was a decrease in blood pressure noted.Anesthesia administered medication to raise the blood pressure, however, the patient's blood pressure remained unstable.An aortogram was performed and it was noted that the patient had wide open aortic insufficiency.Cardiac tamponade was not observed.The patient was then intubated and cpr was required for stabilization and to circulate medication.The navitor was deployed to 80%, but hemodynamic instability persisted.Cpr was reinitiated and medication continued to be administered.The valve was deployed and an impella was placed to help suppose the patient hemodynamically.Assessment of the positioning and depth of the valve were unable to be obtained due to hemodynamic instability.The patient was transferred to the icu and subsequently 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: 50135357
• Report Number: 2135147-2026-05315
• Device Sequence Number: 5597641
• Product Code: NPT
• UDI-Device Identifier: 05415067045768
• UDI-Public: (01)05415067045768(17)280205
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2026

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-35
• Device Catalogue Number: NVRO-35
• Device Lot Number: 10739957
• 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: 07/10/2026
• Initial Report FDA Received Date: 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2025
• 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
• Patient Sex: Male