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 Bradycardia (1751)

Event Date 03/27/2024

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 a 25mm navitor transcatheter aortic valve was selected for implant on (b)(6) 2024 using a small flexnav delivery system.There was calcification extending beneath the aortic annular plane in the interventricular septum.The device was implanted.The final implant depth was 4mm at the non-coronary cusp and 3mm at the left coronary cusp.The patient was kept in the hospital overnight on telemetry and was scheduled for release on (b)(6) 2024 with a monitor.The following day it was observed that the patient experienced brief periods of bradycardia.It was believed that the bradycardia may have been caused by the balloon or the wire.A permanent pacemaker was implanted.The patient status was stable.

Manufacturer Narrative

An event of patient effects bradycardia was reported.A returned device assessment could not be performed as the device 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.Information from the field indicated that there was calcification extending beneath the aortic annular plane in the interventricular septum.The device was implanted.The final implant depth was 4mm at the non-coronary cusp and 3mm at the left coronary cusp.Then, the patient experienced brief periods of bradycardia.It was believed that the bradycardia may have been caused by the balloon or the wire.A permanent pacemaker was implanted.Based on the information received, the cause of the reported bradycardia could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

Event Description

It was reported that a 25mm navitor transcatheter aortic valve was selected for implant on (b)(6) 2024 using a small flexnav delivery system.There was calcification extending beneath the aortic annular plane in the interventricular septum.The device was implanted.The final implant depth was 4mm at the non-coronary cusp and 3mm at the left coronary cusp.The patient was kept in the hospital overnight on telemetry and was scheduled for release on (b)(6) 2024 with a monitor.The following day it was observed that the patient experienced brief periods of bradycardia.It was believed that the bradycardia may have been caused by the balloon or the wire.A permanent pacemaker was implanted.The patient status was stable.

• 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: 19164477
• MDR Text Key: 340835262
• Report Number: 2135147-2024-01810
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031587
• UDI-Public: (01)05415067031587(17)260222(10)8943847
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: NVTR-25
• Device Lot Number: 8943847
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/23/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female