MAUDE Adverse Event Report: ABBOTT MEDICAL FLEXNAV DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Catalog Number FNAV-DS-LG

Device Problems Retraction Problem (1536); Difficult to Advance (2920); Material Twisted/Bent (2981)

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

Event Date 02/15/2024

Event Type  malfunction  

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 29mm navitor transcatheter aortic valve was selected for implant on (b)(6) 2024 using a large flexnav delivery system.During the procedure it was noted that there was resistance whilst advancing the device past the left iliac.After multiple attempts the device was advanced past the left iliac.The first deployment was noted as too shallow.It was observed that fully re-capturing the device could not be completely retracted.The decision was made to deploy the device in the ascending aorta above the sinotubular junction (stj).A kink was noted on the delivery system once removed from the patient.A new 29mm navitor transcatheter aortic valve was selected for implant using a new large flexnav delivery system.It was noted that the delivery system was unable to advance around the aortic arch.The valve and delivery system were removed from the patient.The procedure was aborted.

Manufacturer Narrative

An event of difficulty advancing through patient anatomy, retraction problem, and kinked material was reported.Information from the field indicated that the multiple attempts were needed to get the delivery system past the left iliac.After a deployment attempt, it was observed that the valve could not be fully retracted into the delivery system.After deployment, a kink was noted on the delivery system once removed from the patient.Based on the available information, a cause for the reported advancement difficulty through patient anatomy could not be conclusively determined.It is possible that the patient had challenging or tortuous anatomy.However, this cannot be confirmed.The reported retraction problem appears to be related to the kinked delivery system, and the kinked delivery system appears to be a result of the difficult advancement.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: FLEXNAV DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18877696
• MDR Text Key: 337567112
• Report Number: 2135147-2024-01073
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031389
• UDI-Public: (01)05415067031389(17)250630(10)9138320
• 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: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FNAV-DS-LG
• Device Lot Number: 9138320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/12/2023
• 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: LARGE FLEXNAV DS [FNAV-DS-LG, LOT: 9138320]
• Patient Age: 80 YR
• Patient Sex: Female