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

Catalog Number FNAV-DS-LG

Device Problems Difficult to Insert (1316); Detachment of Device or Device Component (2907); Difficult to Advance (2920)

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

Event Date 01/30/2024

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 a 25mm navitor transcatheter aortic valve was selected for implant on (b)(6) 2024 using a large flexnav delivery system.It was noted that there was resistance when inserting the delivery system into the patient anatomy.The device was successfully implanted.It was observed post-implant, while removing the delivery system from the patient anatomy, the nosecone detached from the delivery system.Fluoroscopy was used to view the nosecone in the access site.A cut down was performed to remove the nosecone.The operator speculated that the detachment of the nosecone may have been due to not fully retracting the capsule after implant before removing the device.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays in the procedure.There were no adverse effects to the patient.The patient status was stable.

Event Description

It was reported that a 25mm navitor transcatheter aortic valve was selected for implant on (b)(6) 2024 using a large flexnav delivery system.It was noted that there was resistance when inserting the delivery system into the patient anatomy.The device was successfully implanted.It was observed post-implant, while removing the delivery system from the patient anatomy, the nosecone detached from the delivery system.Fluoroscopy was used to view the nosecone in the access site.A cut down was performed to remove the nosecone.The operator speculated that the detachment of the nosecone may have been due to not fully retracting the capsule after implant before removing the device.The patient remained hemodynamically stable throughout the procedure.The patient status was stable.

Manufacturer Narrative

An event of insertion difficulty and the nose cone of the device being detached from a delivery system was reported.Information from the field indicated that resistance was observed when the physician tried to insert the sheath into the patient.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on available information, the reported event could not conclusively be determined but could have been due to not retracting the capsule fully after implant before removing device.H6 medical device problem code: code 2920 removed.

• 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: 18753630
• MDR Text Key: 335933441
• Report Number: 2135147-2024-00798
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031389
• UDI-Public: 05415067031389
• 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: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: FNAV-DS-LG
• Device Lot Number: 8826472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2023
• 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: 25MM NAV TRANS AORT VALVE [NVTR-25, LOT: 19935487]
• Patient Outcome(s): Required Intervention
• Patient Sex: Male