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

Model Number	NVRO-29
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 29mm 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 less than 3mm.There was no calcification extending beneath the aortic annular plane in the interventricular septum.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed by using a 23mm, non-abbott balloon.After the pre-bav, the patient's rhythm was observed with premature ventricular contractions (pvcs).During the procedure, the valve was able to be implanted at a depth of 3mm on the non-coronary cusp (ncc) and 4mm on the left-coronary cusp (lcc).The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported.Post-implant, the patient went into a complete heart block, and a temporary pacemaker was placed to stabilize the event.On the following day, a permanent pacemaker was implanted to resolve the event.The patient had discharged, the implanter classified this event as being related to the performance of the non-abbott pre-bav device.
Additional Manufacturer Narrative
An event of heart block was reported intra-procedure.The reported unexpected medical intervention was result of case specific circumstances, as temporary pacemaker was used.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.Based on the available information the cause for the reported heart block cannot be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 50356587
• Report Number: 2135147-2026-05698
• Device Sequence Number: 10232208
• Product Code: NPT
• UDI-Device Identifier: 05415067045775
• UDI-Public: (01)05415067045775(17)280318
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/20/2026

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-29
• Device Catalogue Number: NVRO-29
• Device Lot Number: 10806933
• 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: Not provided
• Initial Report FDA Received Date: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2025
• 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 Sex: Unknown