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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the navitor valve migrated towards aorta after full deployment.The device remains implanted and will not return to abbott for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Request was made for procedure imaging; however, this information was not supplied by the site.Based on the information received from field, the cause of the reported valve migration could not be conclusively determined.The surgical intervention was a result of valve-in-valve implant.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
Clinical information: (b)(4) - envision ide study, patient site id: (b)(6).It was reported that on (b)(6) 2026, a 35mm navitor vision valve was chosen for implant using a large flexnav delivery system.There was sufficient amount of calcium present (1880) to allow anchoring of the device in the opinion of the user.The patient's aortic valve angle (av angle from 3mensio) was about 50 degrees.The annular dimensions of the native valve were 671 mm2 and perimeter 93mm.During procedure, the activated clotting levels were 400s and heparin was given.A pre-implant balloon valvuloplasty was done with a 28mm non-abbott balloon.The final implant depth at left coronary cusp (lcc) was 4.5mm.After full valve deployment, the valve noted to have migrated towards aorta.The implanter believed the cause of migration was insufficient anchoring.The patient was reported stable but the valve was not in an acceptable position and the gradient was high.They decided to implant a second valve.Anew non-abbott valve was chosen and competed the procedure.The patient was reported discharged on (b)(6) 2026.
Event or Problem Description
Clinical information: crd_1066 - envision ide study, patient site id: (b)(6).It was reported that on (b)(6) 2026, a 35mm navitor vision valve was chosen for implant using a large flexnav delivery system.There was sufficient amount of calcium present (1880) to allow anchoring of the device in the opinion of the user.The patient's aortic valve angle (av angle from 3mensio) was about 50 degrees.The annular dimensions of the native valve were 671 mm2 and perimeter 93mm.During procedure, the activated clotting levels were 400s and heparin was given.A pre-implant balloon valvuloplasty was done with a 28mm non-abbott balloon.The final implant depth at left coronary cusp (lcc) was 4.5mm.After full valve deployment, the valve noted to have migrated towards aorta.The implanter believed the cause of migration was insufficient anchoring.The patient was reported stable but the valve was not in an acceptable position and the gradient was high.They decided to implant a second valve.Anew non-abbott valve was chosen and competed the procedure.The patient was reported discharged 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 ; 6517565400
• MDR Report Key: 24369020
• Report Number: 2135147-2026-00968
• Device Sequence Number: 21252474
• Product Code: NPT
• UDI-Device Identifier: 05415067045768
• UDI-Public: (01)05415067045768(17)280217
• 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,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 10760757
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2025
• 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 Age: 69 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White