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

Catalog Number NVTR-25

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Heart Block (4444)

Event Date 04/02/2024

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 02 april 2024, a 25mm navitor valve was chosen for implantation utilizing a small flexnav delivery system.The patient presented with right bundle branch block (rbbb).Pre-dilatation was performed via balloon annular valvuloplasty (bav).During first deployment attempt the valve was too shallow so recapture was attempted.At this point, the patient's rbbb worsened to complete heart block.The valve could not be fully returned to the valve capsule, even when the recapture wheel was maximum applied and the micro adjustment wheel was applied.The flexnav was brought in the descending aorta where the valve capsule was observed to be deformed near the distal end.The flexnav and navitor were removed from the patient without patient injury, and replacement 25mm navitor (serial: (b)(6)) device were implanted successfully at a depth of non-coronary cusp (ncc): 2mm, left coronary cusp (lcc):3mm utilizing a small flexnav (lot: 9119719).The patient left the operating room with a temporary pacemaker.The next day, the patient's heart block resolved back to the pre-existing rbbb.There was no clinically significant delay and the patient remained hemodynamically stable throughout the procedure.

• 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: 19182448
• MDR Text Key: 341118152
• Report Number: 2135147-2024-01843
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031587
• UDI-Public: (01)05415067031587(17)260528(10)9106860
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NVTR-25
• Device Lot Number: 9106860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/29/2023
• 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
• Treatment: SMALL FLEXNAV DELIVERY SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male