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	Atrial Fibrillation (1729); Cardiac Arrest (1762)
Date of Event	06/30/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported on (b)(6) 2026 a 23mm navitor vision valve was selected for implant.During the procedure, when the device was deployed at 80% the patient went into atrial fibrillation several times.Cardioversion was performed to stabilize the patient, and the device was partially re-sheathed and re-positioned.The device was implanted.The final implant depth was 3mm from the non-coronary cusp (ncc).Post-implant the patient went into several cardiac arrests.It was noted that the left coronary artery was low with a height of 10mm.A stent was implanted to slow flow.Cardioversion, cardio massage, and atropine and anocoron were administered.However, after the sixth cardiac arrest, the patient passed away.The cause of death was determined to be the occlusion of the left coronary artery.
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported on (b)(6) 2026 a 23mm navitor vision valve was selected for implant.During the procedure, when the device was deployed at 80% the patient went into atrial fibrillation several times.Cardioversion was performed to stabilize the patient, and the device was partially re-sheathed and re-positioned.The device was implanted.The final implant depth was 3mm from the non-coronary cusp (ncc).Post-implant the patient went into several cardiac arrests.It was noted that the left coronary artery was low with a height of 10mm.A stent was implanted to slow flow.Cardioversion, cardio massage, and atropine and anocoron were administered.However, after the sixth cardiac arrest, the patient passed away.The cause of death was determined to be the occlusion of the left coronary artery.
Additional Manufacturer Narrative
An event of cardiac arrest, atrial fibrillation, and patient death were reported.A returned device assessment could not be performed as the device remains implanted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Information from the field indicated that the final implant depth was 3mm from the ncc.Post-implant the patient went into several cardiac arrests.It was noted that the left coronary artery was low with a height of 10mm.A stent was implanted to slow flow.Cardioversion, cardio massage, and atropine and anocoron were administered.However, after the sixth cardiac arrest, the patient passed away.Aditionally, a medical review was performed by an abbott representative: stating "narrative and limited fluoroscopy video was provided and reviewed.Preprocedural ct imaging and report were not provided.The patient presented with aortic stenosis and was planned for treatment with a 23 mm navitor valve.During deployment, at approximately 80% release, the patient decompensated, requiring cpr and resuscitative efforts.The valve was subsequently fully deployed.Per the narrative, left coronary artery (lca) obstruction occurred.Review of the available imaging suggests coronary occlusion, likely secondary to sinus sequestration.The valve appears constrained at the level of the sinotubular junction (stj), which likely contributed to the patient's hemodynamic collapse and subsequent death." based on the available information, the root cause of the reported death could be due to occlusion of the left coronary artery.A surgical intervention was a result of case specific circumstances, as a stent was implanted.An event of unexpected medical intervention was a case specific circumstances, as cpr was performed and medication was given.

• 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: 50009914
• Report Number: 2135147-2026-05046
• Device Sequence Number: 6000608
• Product Code: NPT
• UDI-Device Identifier: 05415067045805
• UDI-Public: (01)05415067045805(17)281217
• 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): 09/21/2026

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: 11199206
• 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: 06/30/2026
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2025
• 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; Disability; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female