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

Model Number	NVTR-29
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains 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 29 mm navitor valve was selected for implant using a large flexnav delivery system (ds).Baseline was noted to be normal sinus rhythm.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed using an unknown balloon.The patient went into a complete heart block, and a temporary pacemaker was placed to stabilize the rhythm.During the procedure, the valve was able to be implanted at a depth of 5mm on the non-coronary cusp (ncc) and 6mm on the left-coronary cusp (lcc).On the following day, the patient received a permanent pacemaker.The patient was in a stable condition.
Additional Manufacturer Narrative
Correction: report 2135147-2026-01315 has been identified as a duplicate event.The same event/issue was previously reported in report 2135147-2026-01271.The final report including the investigation results for this event was submitted under 2135147-2026-01271-01.
Event or Problem Description
It was reported that on (b)(6) 2026, a 29 mm navitor valve was selected for implant using a large flexnav delivery system (ds).The patient did not have a prior medical history of right branch bundle block (rbbb), left branch bundle block (lbbb) and atrioventricular (av) block.The length of the membranous septum was 3mm.There was calcification extending beneath the aortic annular plane in the interventricular septum.Baseline was noted to be normal sinus rhythm.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed using an unknown balloon.The patient went into a complete heart block, and a temporary pacemaker was placed to stabilize the rhythm.During the procedure, the valve was able to be implanted at a depth of 5mm on the non-coronary cusp (ncc) and 6mm on the left-coronary cusp (lcc).The patient remained hemodynamically stable throughout the procedure with the use of medication and temporary pacemaker, and there was no clinically significant delay reported.On the following day, the patient received a permanent pacemaker.The patient had an extended hospitalization.The implanter classified this event as being related to the performance of the pre-bav device and procedure.The patient was in a stable condition and subsequently discharged.Additional information was received on 17 mar.2026 confirming that this file is a duplicate of (b)(4) | (b)(6).

• Brand Name: NAVITOR TRANSCATHETER AORTIC VALVE
• 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: 24490138
• Report Number: 2135147-2026-01315
• Device Sequence Number: 5091920
• Product Code: NPT
• UDI-Device Identifier: 05415067031600
• UDI-Public: (01)05415067031600(17)260412
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 04/10/2026

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 Expiration Date: 04/12/2026
• Device Model Number: NVTR-29
• Device Catalogue Number: NVTR-29
• Device Lot Number: 9023326
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male