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

Catalog Number NVTR-29

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2024

Event Type  malfunction  

Event Description

It was reported that a 29mm navitor transcatheter aortic valve was selected for implant on (b)(6) 2024.The patient had a pre-existing condition of severe aortic stenosis.During implant it was observed that while attempting to position the device, the device was maneuvered to the descending aorta to close the gap between the valve capsule and nosecone.It was noted that the non-abbott guidewire jumped from the ventricular position.The device was removed from the patient.During device preparation with the same valve and new large flexnav delivery system, it was noted that one of the leaflets was more wrinkled and had what appeared to be a "bite zone".The 29mm valve was replaced with a new 29mm navitor transcatheter aortic valve.The patient did not present with any clinical signs or symptoms.The patient status was stable.

Manufacturer Narrative

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

• 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: 19113531
• MDR Text Key: 340229394
• Report Number: 2135147-2024-01707
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031600
• UDI-Public: (01)05415067031600(17)251120(10)8795661
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NVTR-29
• Device Lot Number: 8795661
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/21/2022
• 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
• Treatment: LARGE FLEXNAV DS [FNAV-DS-LG, LOT: 9136912]; SAPPHIRE2 EXTRA SMALL GUIDEWIRE