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

Model Number	NVRO-35
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Cardiac Arrest (1762); Ventricular Fibrillation (2130)
Date of Event	04/01/2026
Type of Reportable Event	Death
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 25mm navitor vision valve was selected for implant using a small flexnav delivery system (ds).The patient has a prior medical history of right branch bundle block (rbbb).Prior to the procedure, the patient was in a stable condition.There was no calcification extending beneath the aortic annular plane in the interventricular septum.During the pre-implant balloon valvuloplasty, the patient experienced cardiac arrest followed by ventricular fibrillation; pre-bav was performed using a 26mm, non-abbott balloon.The physician immediately proceeded with implantation of the valve in an attempt to stabilize the patient.During the procedure, the valve was able to be implanted at a depth of 4mm on the non-coronary cusp (ncc), however, the patient remained in atrioventricular fibrillation.Cardiopulmonary resuscitation (cpr) maneuvers were initiated, associated with the use of an automated external defibrillator (aed), with multiple attempts at rhythm reversal every two minutes.Concurrently, the echocardiographer performed a detailed evaluation to rule out pericardial effusion and to investigate other parameters that could explain the event.No abnormalities compromising cardiac function and pericardial effusion were identified.After one hour of continuous efforts, there was no recovery of cardiovascular function, resulting in the patient¿s death and the official cause of death was cardiopulmonary arrest.
Event or Problem Description
It was reported that on (b)(6)2026, a 35mm navitor vision valve was selected for implant using a small flexnav delivery system (ds).The patient has a prior medical history of right branch bundle block (rbbb).Prior to the procedure, the patient was in a stable condition.There was no calcification extending beneath the aortic annular plane in the interventricular septum.During the pre-implant balloon valvuloplasty, the patient experienced cardiac arrest followed by ventricular fibrillation; pre-bav was performed using a 26mm, non-abbott balloon.The physician immediately proceeded with implantation of the valve in an attempt to stabilize the patient.During the procedure, the valve was able to be implanted at a depth of 4mm on the non-coronary cusp (ncc), however, the patient remained in atrioventricular fibrillation.Cardiopulmonary resuscitation (cpr) maneuvers were initiated, associated with the use of an automated external defibrillator (aed), with multiple attempts at rhythm reversal every two minutes.Concurrently, the echocardiographer performed a detailed evaluation to rule out pericardial effusion and to investigate other parameters that could explain the event.No abnormalities compromising cardiac function and pericardial effusion were identified.After one hour of continuous efforts, there was no recovery of cardiovascular function, resulting in the patient¿s death and the official cause of death was cardiopulmonary arrest.
Additional Manufacturer Narrative
An event of atrial fibrillation, ventricular fibrillation, cardiac arrest, and death was reported.Additionally, the event was further reviewed by an abbott director medical affairs.The reviewer noted: ¿narrative reviewed; pre ct 3mensio report provided and 4 cell phone short fluroscopic angio videos.A patient with severe aortic stenosis and a history of rbbb underwent tavi with 35 mm navitor titan valve.During the procedure, the patient developed ventricular fibrillation and cardiac arrest prior to valve implantation, during pre-diliation with a 26 mm atlas balloon.The valve was implanted in an attempt to hemodynamically stabilize the patient; however, despite prolonged cpr and repeated defibrillation attempts, the patient could not be resuscitated.Echocardiography reportedly showed no pericardial effusion or other structural abnormalities.The reported cause of death was cardiopulmonary arrest.No device deployment issues, recaptures, or device malfunctions were reported.Based on the available information, the ventricular fibrillation and cardiac arrest preceded valve implantation, and there is no evidence of device-related malfunction or complication.The death is therefore considered most likely related to procedural and/or patient factors rather than device performance." 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 all available information, causes for the reported death, atrial fibrillation, ventricular fibrillation, and cardiac arrest could not be conclusively determined.It is possible that patient condition contributed to this event.However, this cannot be confirmed.The reported unexpected medical interventions were a result of case-specific circumstances as cpr was performed and medications were administered.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: medical device problem code: 2017.

• 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: 24986754
• Report Number: 2135147-2026-02735
• Device Sequence Number: 21257349
• Product Code: NPT
• UDI-Device Identifier: 05415067045768
• UDI-Public: (01)05415067045768(17)280428
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 07/30/2026

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-35
• Device Catalogue Number: NVRO-35
• Device Lot Number: 10932207
• 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: 04/01/2026
• Supplement Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2025
• 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: Death
• Patient Sex: Unknown