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	04/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of heart block was reported.A returned device assessment could not be performed as the device remained implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the received information, the cause of the reported heart block could be due to procedure and the patients' medical history.However, this could not be confirmed.The reported surgical intervention was a result of case specific circumstance as permanent pacemaker was implanted.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 35mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).The patient did not have a history of right branch bundle block (rbbb), left bundle branch block (lbbb) or1st/2nd degree atrioventricular (av) block.The length of the membranous septum was not measured.There was no calcification extending beneath the aortic annular plane in the interventricular septum.Baseline was normal sinus rhythm (nsr).Pre-implant balloon valvuloplasty (pre-bav) was performed using a 25mm, non-abbott balloon with the support of temporary pacing at 180 beats per minute.During the procedure on the first attempt, at 80 percent, the valve was observed to be low, so a partial recapture was performed.On the second attempt, the valve was able to be implanted successfully at a depth of 4mm both on the non-coronary cusp (ncc) and left-coronary cusp (lcc).Post-procedure less than 48 hours, the patient was observed to be in nsr with a new left bundle branch block (lbbb).The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported.On the following day, the patient was developed with a complete heart block.A permanent pacemaker was implanted to resolve the event.The implanter classified this event as being related to the procedure and the patient¿s past medical history.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 ; 6517565400
• MDR Report Key: 25236957
• Report Number: 2135147-2026-03435
• Device Sequence Number: 21231838
• Product Code: NPT
• UDI-Device Identifier: 05415067045768
• UDI-Public: (01)05415067045768(17)280304
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 05/20/2026

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-35
• Device Catalogue Number: NVRO-35
• Device Lot Number: 10785511
• 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: 04/29/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2025
• 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: Male