MAUDE Adverse Event Report: ABBOTT MEDICAL NAVITOR VISION; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	NVRO-35
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 35mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).Baseline was sinus bradycardia, with occasional dropped beats.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed using an unknown balloon.The patient into a complete heart block and it was characterized to be intermittent.During the procedure, the valve was able to be implanted.On an unknown date in (b)(6) 2026, the patient received a permanent pacemaker.The patient was in a stable condition.
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.
Event or Problem Description
It was reported that on (b)(6) 2026, a 35mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).Baseline was sinus bradycardia, with occasional dropped beats.The length of the membranous septum was 6.4mm.There was no calcification extending beneath the aortic annular plane in the interventricular septum.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed using an unknown balloon.The patient went into a complete heart block, and it was characterized to be intermittent.A temporary pacemaker was placed to start the procedure.During the procedure, the valve was able to be implanted at a depth of 6mm on the non-coronary cusp (ncc) and 5mm on the left-coronary cusp (lcc).A temporary pacemaker was left in place to stabilize the cardiac rhythm.The patient remained hemodynamically stable throughout the procedure, and there was no clinically significant delay reported.On an unknown date in (b)(6) 2026, the patient received a permanent pacemaker.The implanter classifies this event as being related to the patient¿s past medical history.The patient was in a stable condition and noted to be discharged.
Additional Manufacturer Narrative
An event of heart block and permanent pacemaker was reported.A more comprehensive assessment could not be performed as limited information was available, and the device was not returned for analysis.Based on the information available, no new hazards or harms were identified that would alter the current benefit¿risk profile.Additionally, there was no evidence of a product issue or concerns regarding the device¿s labeling or design.The unexpected medical intervention was result of case specific circumstances as temporary pacemaker was used.The surgical intervention appears to be specific to the circumstances of the case, as the patient required a permanent pacemaker implant due to the heart block.There is no indication of a product quality issue related to the device¿s labeling, design, or manufacturing.

• 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 ; 6517565400
• MDR Report Key: 24338762
• Report Number: 2135147-2026-00923
• Device Sequence Number: 18585183
• Product Code: NPT
• UDI-Device Identifier: 05415067045768
• UDI-Public: (01)05415067045768(17)280402
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 04/07/2026

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-35
• Device Catalogue Number: NVRO-35
• Device Lot Number: 10827037
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2025
• 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: Male
• Patient Weight: 78 KG