MAUDE Adverse Event Report: ABBOTT MEDICAL Navitor Vision; Aortic Valve, Prosthesis, Percutaneously Delivered

Model Number	NVRO-23
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Perivalvular Leak (1457)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	06/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.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 23mm navitor vision valve was selected for implant using a small flexnav delivery system (ds).Pre-implant balloon aortic valvuloplasty (pre-bav) was performed by using a 20mm, non-abbott ballon.During the procedure, an incomplete stent opening (iso) was observed and was resolved after two recaptures then the valve was able to be implanted at a depth of 3mm on the non-coronary cusp (ncc) and 4mm on the left-coronary cusp (lcc).Post-implant, moderate paravalvular leak (pvl) was observed.Post-implant balloon aortic valvuloplasty (post-bav) was performed by using a 20mm, non-abbott balloon.Mild pvl was observed.; the patient remained hemodynamically stable throughout the procedure.It was also reported that hemostasis could not be achieved using perclose and was able to be achieved by surgical cutdown.The patient's current condition is unknown.
Event or Problem Description
It was reported that on (b)(6) 2026, a 23mm navitor vision valve was selected for implant using a small flexnav delivery system (ds).Pre-implant balloon aortic valvuloplasty (pre-bav) was performed by using a 20mm, non-abbott ballon.During the procedure, an incomplete stent opening (iso) was observed and was resolved after two recaptures then the valve was able to be implanted at a depth of 3mm on the non-coronary cusp (ncc) and 4mm on the left-coronary cusp (lcc).Post-implant, moderate paravalvular leak (pvl) was observed.Post-implant balloon aortic valvuloplasty (post-bav) was performed by using a 20mm, non-abbott balloon.Mild pvl was observed.; the patient remained hemodynamically stable throughout the procedure.It was also reported that hemostasis could not be achieved using perclose and was able to be achieved by surgical cutdown.The patient's current condition is unknown.
Additional Manufacturer Narrative
An event of paravalvular leak (pvl) and valve under-expansion 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 (pvl) and valve under expansion that resulted in aortic valve insufficiency could not be conclusively determined.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 ; +1(651)756-5400
• MDR Report Key: 25785721
• Report Number: 2135147-2026-04790
• Device Sequence Number: 16116365
• Product Code: NPT
• UDI-Device Identifier: 05415067045805
• UDI-Public: (01)05415067045805(17)281021
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/28/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: NVRO-23
• Device Catalogue Number: NVRO-23
• Device Lot Number: 11096706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2025
• 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: Unknown