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

Model Number	NVTR-27
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Incomplete Coaptation (2507); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, a 27mm navitor valve was selected for implant using a large flexnav delivery system (ds).Pre-implant balloon aortic valvuloplasty (pre-bav) was performed by using a 24mm, non-abbott balloon.During the procedure, the valve was able to be implanted at a depth of approximately 5mm on the non-coronary cusp (ncc).Post-implant, severe transvalvular aortic regurgitation was observed with a gradient of 7.6mmhg.Transesophageal echocardiography (tee) demonstrated markedly restricted mobility of one of the leaflets, resulting in inadequate leaflet coaptation and impaired hemodynamics presented with low blood pressure and high left ventricle (lv) end-diastolic pressure.Post-implant balloon aortic valvuloplasty (post-bav) was performed by using a 24mm, non-abbott balloon.During post-bav, angiography revealed significant recoil of the valve.Following post-bav, no improvement in leaflet mobility, regurgitation severity, or hemodynamics were observed.While preparing for the second valve, the patient's conditions improved spontaneously with restoration of normal mobility of all three valve leaflets, improved hemodynamics and trace residual paravalvular leak (pvl).Therefore, second valve was not implanted.The user believed the valve expanded non-uniformly because in the right-left (rl) cusp overlap view the expansion appeared to be slightly less than in 3-cusp view.The patient was discharged with no pvl.
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 Transcatheter Aortic Valve
• 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: 50818053
• Report Number: 2135147-2026-06296
• Device Sequence Number: 10677642
• Product Code: NPT
• UDI-Device Identifier: 05415067031594
• UDI-Public: (01)05415067031594(17)290216
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 09/18/2026

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: NVTR-27
• Device Catalogue Number: NVTR-27
• Device Lot Number: 11303469
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2026
• 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 Sex: Unknown