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	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 27 mm navitor vision valve was selected for implant using a large flexnav delivery system.Pre-procedure, the patient was in normal sinus rhythm (nsr).The patient had no reported history of right bundle branch block (rbbb), left bundle branch block (lbbb), or first-/second-degree atrioventricular block.The membranous septum length was reported as less than 3 mm.No calcification extending beneath the aortic annular plane into the interventricular septum was reported.Access was obtained via the femoral approach.During the procedure, pre-dilation was performed using a 22 mm non-abbott balloon.During loading, no issues were reported retracting the valve into the delivery system.No issues were reported leading the retainer tabs into the retainer receptacle.No increase in drag was noted on the deployment/re-sheath wheel during loading.While in the cusp overlap view (cov), the inflow edge of the constrained valve within the capsule was positioned at the base of the aortic annulus and the pigtail position was confirmed at the bottom of the non-coronary cusp (ncc).During 80% deployment, the valve would not stay in place and repeatedly slipped down into the left ventricle (lv).There was sufficient calcium present to support the expectation that the valve would not move ventricularly.Annular measurements performed by both the reporter and the hospital were reportedly consistent with sizing for a 27 mm valve.It was further reported that the presence of sinotubular junction (stj) calcium was not believed to be influencing the valve movement, as the calcium was located above the valve frame height.At approximately 80% deployment of the navitor valve, the patient developed complete heart block.After three recaptures, the physician decided to abort the navitor implantation and implant a 23 mm non-abbott valve.The navitor valve was not implanted.The 23 mm non-abbott replacement valve was successfully implanted.Post-procedure electrocardiogram (ecg) showed complete heart block and the patient left the cath lab with a temporary pacemaker in place.It was further reported that a permanent pacemaker was required following the procedure.The patient did not experience a prolonged hospital stay for rhythm monitoring.The patient remained hemodynamically stable throughout the procedure.No clinically significant delay was reported.The physician attributed the complete heart block to valve interaction with the patient's anatomy.The patient was discharged.
Additional Manufacturer Narrative
The device is not returning 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: 50261448
• Report Number: 2135147-2026-05616
• Device Sequence Number: 10635042
• Product Code: NPT
• UDI-Device Identifier: 05415067045799
• UDI-Public: (01)05415067045799(17)280330
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/14/2026

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: 10828989
• 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: 07/21/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FlexNav, FNAV-DS-LG
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown