MAUDE Adverse Event Report: ABBOTT MEDICAL FLEXNAV DS; SMALL FLEXNAV DELIVERY SYSTEM

Model Number FNAV-DS-SM

Device Problems Use of Device Problem (1670); Material Twisted/Bent (2981)

Patient Problem Perforation of Vessels (2135)

Event Date 06/03/2022

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 on (b)(6) 2022, a small flexnav delivery system was selected for procedure.When advancing the delivery system to the patient's annulus, a kink in the inner shaft marker band was noticed.It was also noted that there had been difficulty advancing the delivery system and a balloon dilatation was performed, but the delivery system still failed to advance even when pushing hard.The patient had a severely calcified vessel.It was noted that at an unknown point during procedure, the patient had suffered perforation from the external iliac artery to the common iliac artery.The decision was made to conduct a surgery to implant an unknown vascular graft and percutaneous angioplasty to place an unknown stent graft to complete the procedure.There was no clinically significant delay in procedure reported.The patient was discharged at the time of report.The cause of the perforation of the patient's vasculature is believed to have been either the small flexnav delivery system or the unknown balloon catheter, but it is unknown for certain.No additional information was provided.

Manufacturer Narrative

An event of kink in delivery system during advancement of the device and perforation from the external iliac artery to the common iliac artery was reported.The device was returned to abbott and investigation confirmed device was kinked, which could have been caused by advancing the device through the patient.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 the user did not think that the device malfunctioned and that the patient had a severely calcified vessel, which could have contributed to the damage noted to the device.The cause of the perforation could not be conclusively determined.

• Brand Name: FLEXNAV DS
• Type of Device: SMALL FLEXNAV DELIVERY SYSTEM
• 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: 16178948
• MDR Text Key: 307491865
• Report Number: 2135147-2023-00204
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031372
• UDI-Public: 05415067031372
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: FNAV-DS-SM
• Device Catalogue Number: FNAV-DS-SM
• Device Lot Number: 8359761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female