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

Model Number	NVRO-35
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on 26 aug.2026, a 35mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).Femoral vessel was selected as the access site, and the patient was in a normal sinus rhythm with pre-gradient measured as 49mmhg.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed by using a 26mm, non-abbott balloon.During the procedure, on the first attempt, the valve was positioned too high and it was required to be recaptured.On the second attempt, non-abbott wire pushed the valve to jump up higher therefore the ds was pulled into the ascending aorta and a recapture was performed.On fluoroscopy, kink was observed and it was reported that all (3) retainer tabs were detached and removed from the patient's anatomy with the gap closed.A second 35mm, navitor vision valve was selected for implant using a new large flexnav ds.The valve was recaptured due to the positioning issues, and it was pulled into the ascending aorta to recapture the valve.During the recapture, it was observed that the valve had detached partially and it was removed from the patient's anatomy with the gap closed.A third 35mm, navitor vision valve was selected for implant using a new large flexnav ds.On the first attempt, the valve was positioned too high and attempted to recapture, and it jumped a bit so pulled into the ascending aorta then a full recapture was successfully performed.On the second attempt, the valve was in a deeper position in lao view then the wire tension was released.The valve was able to be implanted at a depth of 3-4mm on the non-coronary cusp (ncc).An incomplete stent opening (iso) was observed; post-implant balloon aortic valvuloplasty (post-bav) was performed by using a 26mm, non-abbott balloon due to iso.Post-gradient was measured as 0mmhg.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported.The user believed the valve expanded non-uniformly since the native annulus was severely calcified.The patient was in a stable condition.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.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: 50819205
• Report Number: 2135147-2026-06311
• Device Sequence Number: 16130630
• Product Code: NPT
• UDI-Device Identifier: 05415067045768
• UDI-Public: (01)05415067045768(17)290310
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/18/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: NVRO-35
• Device Catalogue Number: NVRO-35
• Device Lot Number: 11411863
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2026
• 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
• Patient Age: 80 YR
• Patient Sex: Male