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

Model Number	NVRO-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Vascular Dissection (3160); Pericardial Effusion (3271)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
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).The patient has a prior medication history of 30 mg, lixiana® (edoxaban).Pre-implant balloon aortic valvuloplasty (pre-bav) was performed by using a 23mm, non-abbott balloon.Upon insertion of 260cm, spring wire (non-abbott brand, j-tip) into the left ventricle, the patient's blood pressure became low, and an unclear percutaneous cardiopulmonary support (pcps) was performed.During the procedure, the valve was able to be implanted.Post-implant, aortic root rupture and a type b dissection had occurred; small amount of circumferential pericardial effusion was observed to be at the apex of heart.Pericardiocentesis was attempted to resolve the event.However, the procedure was aborted because the amount of pericardial effusion was minimal, and further puncture was considered too risky.Ecmo (extracorporeal membrane oxygenation) was subsequently initiated.The physician(s) concluded the presence of cardiac tamponade.The user believed the cause of pericardial effusion to be due to the 23mm, non-abbott balloon.Ecmo has been discontinued; however, the patient remains intubated and on ventilatory support.The patient is hospitalized.
Additional Manufacturer Narrative
The device remains 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 ; +1(651)756-5400
• MDR Report Key: 50181062
• Report Number: 2135147-2026-05426
• Device Sequence Number: 18613456
• Product Code: NPT
• UDI-Device Identifier: 05415067045805
• UDI-Public: (01)05415067045805(17)280722
• 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
• Report Date (Section B): 08/07/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: NVRO-23
• Device Catalogue Number: NVRO-23
• Device Lot Number: 10992478
• 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: 07/13/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2025
• 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; Hospitalization; Life Threatening
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 145 LB