MAUDE Adverse Event Report: ABBOTT MEDICAL NAVITOR VISION; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	NVRO-35
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Adverse Event Without Identified Device or Use Problem (2993); Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Low Blood Pressure/ Hypotension (1914)
Date of Event	03/19/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2026, a 35 mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).During the procedure, the valve was able to be implanted at a depth of 3-4 mm on the non-coronary cusp (ncc).No adverse health consequences were reported.On the following day, the patient had clinical condition had deteriorated with hemodynamic instability being observed.Post-implant balloon valvuloplasty (post-bav) was performed using a 24 mm and twice with 26 mm, non-abbott balloon.On the following day, the patient was pronounced to deceased.The implanter classified this death likely related to the procedure and the patient¿s comorbidities since he stated that the valve looked fine.
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.
Additional Manufacturer Narrative
An event of incomplete stent opening, device stenosis, aortic valve stenosis, hypotension, and death were reported.A returned device assessment could not be performed as the device remains implanted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.Based on the available information, the cause for the reported incomplete stent opening could not be determined.The reported device stenosis, aortic valve stenosis, hypotension are likely cascading effects from the event.An unexpected medical intervention was a result of case specific circumstances, as a post bav was performed.The reported death is likely related to procedural circumstances and patient¿s comorbidities; however, this cannot be conclusively determined.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.
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).During the procedure, the valve was able to be implanted at a depth of 3-4mm on the non-coronary cusp (ncc).No adverse health consequences were reported.On the following day, the patient had clinical condition had deteriorated with hemodynamic instability being observed.Post-implant balloon valvuloplasty (post-bav) was performed using a 24mm and twice with 26mm, non-abbott balloon.On the following day, the patient was pronounced to deceased.The implanter classified this death likely related to the procedure and the patient¿s comorbidities since he stated that the valve looked fine.

• 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 ; 6517565400
• MDR Report Key: 24916120
• Report Number: 2135147-2026-02544
• Device Sequence Number: 13218584
• Product Code: NPT
• UDI-Device Identifier: 05415067045768
• UDI-Public: (01)05415067045768(17)280507
• 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): 06/19/2026

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: 10880833
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2025
• 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 Age: 75 YR
• Patient Sex: Male