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

Model Number	NVRO-25
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Off-Label Use (1494)
Health Effect - Clinical Codes	Stroke/CVA (1770); Coronary obstruction/occlusion (4871)
Date of Event	08/12/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2026, a 25mm navitor valve with a small flexnav delivery system were chosen for off label transcatheter aortic valve-in-valve procedure of a previously implanted 25mm epic plus valve.During post-dilatation of the 25mm navitor valve with a 24mm non-abbott balloon, it was noted there was a complication involving fracture of the 25mm epic plus valve, and the 25mm navitor valve had migrated in the aortic direction, causing partial right and left coronary artery obstruction.The migrated valve was snared and repositioned to allow coronary access and placement of a new valve.Subsequently, a decision was made to prepare a second 25mm navitor valve with a second new small flexnav delivery system that was successfully implanted within the 25mm epic plus valve.The patient remained hemodynamically stable throughout the procedure.Post-operatively, patient suffered an ischemic stroke, which worsened over time, and ultimately leading to patient death on (b)(6) 2026.
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: 50733844
• Report Number: 2135147-2026-06133
• Device Sequence Number: 18791563
• Product Code: NPT
• UDI-Device Identifier: 05415067045782
• UDI-Public: (01)05415067045782(17)280911
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 09/11/2026

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-25
• Device Catalogue Number: NVRO-25
• Device Lot Number: 11032448
• 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: 08/18/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2025
• 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: 70 YR
• Patient Sex: Unknown