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

Model Number NVTR-27

Device Problem Malposition of Device (2616)

Patient Problem Heart Block (4444)

Event Date 11/15/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2022, a 29mm navitor valve was selected for implant using a large flexnav delivery system.The valve was sized via computerized axial tomography (cat).The valve was never re-sheathed.It was noted after release of the valve that the valve migrated to the patient's ascending aorta.The decision was made to implant a second 27mm navitor valve in the patient to complete the procedure.The cause of migration of the 29mm valve was believed to be due to oversizing.The patient remained hemodynamically stable throughout the procedure.No clinically significant delay in procedure was reported.A day after implant of the 29mm navitor valve, the patient required a permanent pacemaker implant due to developing a complete heart block.This resulted in the patient being hospitalized for an additional 2 days.There was no calcification extending beneath the aortic annular plane in the interventricular septum noted.The patient's baseline rhythm was a sinus rhythm.The final implant depth of the second 27mm navitor valve was about 8mm above the annular plane.The patient was discharged at the time of report.It was reported that the permanent pacemaker implant was not related to the valve procedure.

Manufacturer Narrative

An event of complete heart block requiring permanent pacemaker implant was reported.A returned device assessment could not be performed as the device remains 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 defined manufacturing specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note that per the instructions for use, "deploying the valve: prior to release, use appropriate imaging to ensure the struts at the inflow (lvot) portion of the valve are aligned and confirm the depth of the implant is approximately 3 mm (0.12 in.).".

• Brand Name: NAVITOR TRANSCATHETER AORTIC VALVE
• Type of Device: 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: 16383245
• MDR Text Key: 309634730
• Report Number: 2135147-2023-00535
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031594
• UDI-Public: 05415067031594
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P190023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NVTR-27
• Device Catalogue Number: NVTR-27
• Device Lot Number: 8577578
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention