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

Model Number	NVRO-27
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Perforation (2001); Tachycardia (2095); Cardiac Tamponade (2226); Pericardial Effusion (3271); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	09/02/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported on (b)(6) 2026 a 27mm navitor vision valve was selected for implant using a large flexnav delivery system.The native valve was measured with a perimeter of 74.9mm and area of 435.9mm.The left ventricular outflow tract (lvot) was measured 24.4mm.Thirteen thousand units of heparin were administered.Pre-balloon aortic valvuloplasty was performed with a 23mm non-abbott balloon.During the procedure, the valve popped out at approximately 45% deployment.The patient experienced some chest discomfort.The pigtail catheter was noted to be wrapped around the device.The pigtail was pulled back, and the valve was partially re-sheathed.A second deployment attempt was made at a deeper position per the physician's request.However, the valve popped out again at 45% deployment.A root angiogram was performed and revealed an aortic perforation.The patient then became hemodynamically unstable with low blood pressure and severe aortic regurgitation.To provide stabilization for transport to the operating room, the valve was fully deployed at a depth of 12mm on both the non-coronary cusp (ncc) and left coronary cusp (lcc).The patient then became unresponsive and was emergently intubated.The valve migrated toward the left ventricle at a depth of 15mm on both ncc and lcc.Transesophageal echocardiography (tee) revealed a developing large pericardial effusion, which led to a cardiac tamponade.A pericardiocentesis was performed with near resolution of the effusion.The patient's blood pressure continued to decline, of which cardiopulmonary compressions (cpr) were initiated.A heart pump was inserted for hemodynamic support.The patient's rhythm was ventricular tachycardia twice during resuscitative efforts and required two defibrillations that converted the patient's rhythm back to sinus rhythm.The patients stabilized and was transferred to the operating room, in which the device was surgically explanted.The patient was transferred to cardiovascular intensive care unit (cicu).The aortic stenosis persisted and, the patient passed away later that day.
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 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: 50903153
• Report Number: 2135147-2026-06557
• Device Sequence Number: 13438406
• Product Code: NPT
• UDI-Device Identifier: 05415067045799
• UDI-Public: (01)05415067045799(17)290125
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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-27
• Device Catalogue Number: NVRO-27
• Device Lot Number: 11262329
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2026
• 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
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Sex: Male