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

Model Number	NVRO-27
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of heart block was reported intra-procedure.Patient has a history of cardiac arrhythmias, conduction disturbances, and first degree atrioventricular (av) block.There was calcification at the bottom of the ncc.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.There was calcification extending beneath the aortic annular plane in the interventricular septum and the valve was released with an implant depth of 2 mm from the non-coronary cusp which is higher than optimal implant depth of 3¿9 mm which may have caused the reported complications, and based on the all available information the cause for the reported heart block could be related to the implant depth and/or patient calcification, however, this could not be determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2026, a 27mm navitor vision valve was selected for implant using a flexnav delivery system (ds).The patient did not have a history of right bundle branch block (rbbb), left bundle branch block (lbbb) and 1st/2nd atrioventricular block (av) block.The length of the membranous septum was 2.5mm.During the valve deployment, the patient was developed with a complete atrioventricular block (cavb).The valve was able to be implanted at a depth of 3mm both on the non-coronary cusp (ncc) and left-coronary cusp (lcc).Temporary pacemaker was placed to stabilize the cardiac rhythm.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported.The patient was in a stable condition.

• 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: 50887605
• Report Number: 2135147-2026-06472
• Device Sequence Number: 9827202
• Product Code: NPT
• UDI-Device Identifier: 05415067045799
• 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): 09/24/2026

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: 11251215
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2025
• 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 Age: 81 YR
• Patient Sex: Male