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

Model Number	NVRO-35
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
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.
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).The patient has a horizontal anatomy measuring to be 50 degrees.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed using a 25mm, non-abbott balloon.During the procedure, at 80 percent deployment, the valve was placed at 3mm depth.The valve was able to be implanted, and it was observed to be embolized towards aorta.Post-implant balloon aortic valvuloplasty (post-bav) was performed using a 28mm, non-abbott balloon.The device was repositioned via a snare and the patient became unstable.A surgical intervention was required to treat the replace the aortic valve.The patient remained hemodynamically stable till the embolization, and there was no clinically significant delay reported.The implanter believe was the cause of migration due to excessive calcium.The patient's status was recovering.
Additional Manufacturer Narrative
An event of migration or expulsion of device (aortic direction) was reported.A returned device assessment could not be performed as the device remains implanted and 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.There are also two images that confirm the presence of a snare.The first image shows the snare once attached, and the second image shows how the valve rotated when backward tension was applied.The valve appears to migrate slightly more aortic and shows substantial foreshortening due to the initial degree of constraint.Based on the information received, the cause for the reported device migration in aortic direction could not be conclusively determined.The reported unexpected medical intervention and surgical intervention were result of case-specific circumstances as post-implant valvuloplasty and device was snared.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 24475566
• Report Number: 2135147-2026-01276
• Device Sequence Number: 13331496
• Product Code: NPT
• UDI-Device Identifier: 05415067045768
• UDI-Public: (01)05415067045768(17)280518
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 04/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 10898944
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2025
• 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: Required Intervention
• Patient Sex: Male