MAUDE Adverse Event Report: ABBOTT MEDICAL FLEXNAV DELIVERY SYSTEM; Aortic valve, prosthesis, percutaneously delivered

Catalog Number FNAV-DS-SM

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

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

Event Date 01/13/2023

Event Type  malfunction  

Manufacturer Narrative

An event of advancement difficulty through patient anatomy and catheter damage was reported.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 damage was observed at the opening of the catheter.The field also indicated that the patient had a high degree of calcareous plaque in the femoral artery.The device was returned for analysis.The nosecone and valve capsule were observed to be damaged/deformed.As the event is not reportable, a letter is not requested and there is no indication of a product issue, no device history record or lot specific similar complaint review is required.Based on available information, the cause of the reported event appears to be a result of calcareous plaque in the femoral artery.There is no indication of a product quality issue with respect to manufacture, design, or labeling.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that on 13 january 2023, an unknown valve was chosen for implant using a large flexnav delivery system.It was noted that there was calcareous plaque in the femoral artery.While it was attempted to pass the delivery system through the femoral artery, resistance was encountered.The delivery system was removed, and damage was seen at the opening of the catheter.A new large flexnav delivery system was chosen to implant the valve.The valve was successfully positioned and implanted.The patient remained stable throughout the procedure and there was no clinically significant delay.The patient was reported as stable.

• 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# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17732939
• MDR Text Key: 323229462
• Report Number: 2135147-2023-03960
• 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
• Report Date: 09/12/2023

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-SM
• Device Lot Number: 8767326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2022
• 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