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 Codes	Atrial Fibrillation (1729); Bradycardia (1751); Heart Block (4444)
Date of Event	04/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical information: crd_1059 - vista nova study, patient site id: site id- (b)(6).It was reported that on (b)(6) 2026, a 27mm navitor vision valve was chosen for implant using a large flexnav delivery system.There wasn't calcification present extending beneath the aortic annular plane in the interventricular septum.The activated clotting levels were 183,189s and heparin was given.A pre-implant balloon valvuloplasty (bav) was done with a 20mm non-abbott balloon.After pre-bav, the patient had a left bundle branch block (lbbb).After multiple re-sheath (5 full re-sheath) due to implant too low, the valve got removed and a new valve was used.A new 27mm navitor vision valve and large flexnav delivery system were chosen.The final implant depth was 5.03mm on non-coronary cusp (ncc) and 7.32mm at left coronary cusp (lcc).During hospitalization, patient experienced atrial fibrillation with bradycardia and lbbb.A decision was made to implant a temporary pacemaker on (b)(6) 2026.The patient was reported discharged.
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: 50371963
• Report Number: 2135147-2026-05706
• Device Sequence Number: 5714718
• Product Code: NPT
• UDI-Device Identifier: 05415067045799
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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: 11198225
• 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
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 08/21/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2025
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 143 LB