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

Model Number	NVRO-27
Medical Device Problem Codes	Perivalvular Leak (1457); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/19/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported on (b)(6) 2026 a 27mm navitor vision valve was selected for implant using a large flexnav delivery system.The patient was in sinus rhythm.Blood pressure was between 70mmhg and 100mmhg prior to the procedure.During the procedure it was noted that there was difficulty keeping the delivery system coaxial to the aorta due to the delivery system's inner curvature coming from the right subclavian access.The device was partially re-sheathed twice.The device was implanted.The final implant depth was 3mm from the non-coronary cusp (ncc) and 8mm from the left coronary cusp (lcc).A moderate perivalvular leak (pvl) was noted on the left side.The decision was made to implant a second device to address the pvl.A second 27mm navitor vision valve was implanted at an implant depth of 0mm from the ncc and 5mm from the lcc.Pvl improved to mild; however, the patient remained hypotensive.On the same day the patient passed away.
Event or Problem Description
It was reported on (b)(6) 2026 a 27mm navitor vision valve was selected for implant using a large flexnav delivery system.The patient was in sinus rhythm.Blood pressure was between 70mmhg and 100mmhg prior to the procedure.During the procedure it was noted that there was difficulty keeping the delivery system coaxial to the aorta due to the delivery system's inner curvature coming from the right subclavian access.The device was partially re-sheathed twice.The device was implanted.The final implant depth was 3mm from the non-coronary cusp (ncc) and 8mm from the left coronary cusp (lcc).A moderate perivalvular leak (pvl) was noted on the left side.The decision was made to implant a second device to address the pvl.A second 27mm navitor vision valve was implanted at an implant depth of 0mm from the ncc and 5mm from the lcc.Pvl improved to mild; however the patient remained hypotensive.On the same day the patient passed away.
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 perivalvular leak and death was reported.A returned device assessment could not be performed as the device was not returned for analysis.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 available information, the cause of the reported perivalvular leak and patient death could not be conclusively determined.The reported surgical intervention was a result of case-specific circumstances as another valve was implanted.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: 50737868
• Report Number: 2135147-2026-06170
• Device Sequence Number: 10587085
• Product Code: NPT
• UDI-Device Identifier: 05415067045799
• UDI-Public: (01)05415067045799(17)270606
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 09/23/2026

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: 10402845
• 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: 08/19/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/11/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2024
• 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: Required Intervention; Death
• Patient Sex: Unknown