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

Model Number FNAV-DS-LG

Device Problems Fracture (1260); Difficult to Insert (1316); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

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

Event Date 03/22/2023

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 (b)(6)2023, a flexnav delivery system was chosen for procedure.While the delivery system was advancing through the femoral artery, the capsule of the delivery system suffered a break in the distal portion.This event occurred as the user did not have adequate manipulation of the delivery system.The device was replaced with another flexnav delivery system, and the transcatheter aortic valve implantation was completed successfully.The patient status was reported as stable.

Manufacturer Narrative

An event of "when trying to insert the delivery system into the femoral artery, the valve capsule of the delivery system over captured the radiopaque tip" was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and that the product met all specifications.The cause of the reported event could not be conclusively determined, however, excessive force was applied to the to capsule and the integrated sheath, which caused the distal part of the capsule to advance on to the radiopaque tip.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.H6 medical device problem code: codes 1260 and 2920 removed.

Event Description

It was reported that on (b)(6) 2023, a flexnav delivery system was chosen for procedure.During loading of the valve into the delivery system, there were no crossed or misaligned struts, and the valve was loaded by the abbott representative.Prior to insertion, there was no gap between the valve capsule and the radiopaque tip.When trying to insert the delivery system into the femoral artery, the valve capsule of the delivery system overcaptured the radiopaque tip.This event occurred as the user did not have adequate manipulation of the delivery system and excessive force was applied to the valve capsule integrated sheath.There was no bend of the valve capsule.The device was replaced with another flexnav delivery system, and the transcatheter aortic valve implantation was completed successfully.There was no clinically significant delay in procedure and no adverse patient effects.The patient status 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#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: 16727265
• MDR Text Key: 313647387
• Report Number: 2135147-2023-01597
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031389
• UDI-Public: 05415067031389
• Combination Product (y/n): N
• Reporter Country Code: PE
• 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: 06/15/2023

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 Model Number: FNAV-DS-LG
• Device Catalogue Number: FNAV-DS-LG
• Device Lot Number: 8822283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/12/2023
• Supplement Dates Manufacturer Received: 06/12/2023
• Supplement Dates FDA Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• 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
• Patient Age: 85 YR
• Patient Sex: Female