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 Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	06/10/2026
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 23 mm navitor vision valve was selected for implantation using a small flexnav delivery system.The native annulus measurements were reported as 20.6 in diameter and 64.7 in perimeter.During the procedure, heparin was administered (dose unknown), and the activated clotting time (act) was maintained at >250.After the non-abbott guidewire passed through the annulus, the guidewire twisted within the ventricle.At that time, the physician suspected a pericardial effusion (pe).A transesophageal echocardiogram (tte) was performed; however, no pe was visible at that time.Pre-dilatation was subsequently performed, followed by valve implantation and post-dilatation.Post-dilatation was performed due to perivalvular leak (pvl) and valve underexpansion.There were no reported difficulties during implantation, no multiple manipulations, no multiple wire or delivery sheath exchanges, and the valve was not re-sheathed more than two times.After full release of the navitor valve, a pericardial effusion was noted via tte.The effusion was described as circumferential, with a largest reported volume of 400 ml.No cardiac tamponade was present.At the time the pe was noted, the patient did not exhibit or report respiratory symptoms.¿low rr¿ was documented and clarified to indicate low blood pressure.The pericardial effusion was managed with pericardiocentesis.A reversal agent (protamine) was administered after the procedure.The physician indicated that the pe was related to the procedure and attributed the cause of the pe to the non-abbott guidewire and not the device.The patient remained hemodynamically stable throughout the procedure under medication (noradrenaline).No prolonged or additional hospitalization was required due to this event.The current patient status was reported as stable.No clinically significant delay was reported.

• 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: 25680567
• Report Number: 2135147-2026-04551
• Device Sequence Number: 18569329
• Product Code: NPT
• UDI-Device Identifier: 05415067045805
• UDI-Public: (01)05415067045805(17)280908
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 07/01/2026

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-23
• Device Catalogue Number: NVRO-23
• Device Lot Number: 11063467
• 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: 06/10/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2025
• 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