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

Catalog Number FNAV-DS-SM

Device Problems Difficult to Insert (1316); Difficult to Advance (2920); Material Deformation (2976)

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

Event Date 11/03/2023

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 on 3 november 2023, a small flexnav delivery system was used to deliver a navitor valve.The patient presented with tortuous anatomy.The flexnav was unable to cross the iliac bifurcation on two attempts.The flexnav was removed and the tip was observed to be kinked.A 18f non-abbott introducer sheath was inserted to assist with insertion, but the kinked flexnav could not pass through the introducer.The introducer sheath was changed to a non-abbott 20f and a replacement flexnav with the same navitor valve was able to pass through without issue.There was no patient consequences or clinically significant delay.The patient remained hemodynamically stable throughout the procedure.Patient was reported to be stable.

Manufacturer Narrative

An event of difficulty crossing the iliac bifurcation on two attempts and kink at the tip of flexnav was reported.The delivery system was returned to abbott and the valve capsule was found deformed.The inner membrane was kinked.No other anomalies were noted.Information from field indicated that the patient had tortuous anatomy which may have contributed to the reported event of advancement difficulty and kink at the tip.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported incident could not be conclusively determined, however the damage noted to the device is consistent with damage during use.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 18219577
• MDR Text Key: 329150630
• Report Number: 2135147-2023-05220
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031372
• UDI-Public: 05415067031372
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/15/2024

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 Expiration Date: 03/31/2024
• Device Catalogue Number: FNAV-DS-SM
• Device Lot Number: 8418404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 01/10/2024
• Supplement Dates FDA Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2022
• 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: NAVITOR VALVE
• Patient Age: 93 YR
• Patient Sex: Male