MAUDE Adverse Event Report: Abbott Medical FlexNav Delivery System; Aortic Valve, Prosthesis, Percutaneously Delivered

Model Number	FNAV-DS-LG
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, a navitor valve was selected for implant using a large flexnav delivery system (ds).Pre-implant balloon valvuloplasty (pre-bav) was performed using an unspecified balloon.The same wire was reported to be used for pre-bav, pacing, and the valve implant procedure.During the procedure, the valve was able to be implanted.Upon removal of the ds, it was difficult to remove, and it was removed together with a xs, circulo guidewire.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported.The patient was reported to be discharged.
Additional Manufacturer Narrative
An event of stuck guidewire in the delivery system was reported.The investigation into the returned device confirmed the stuck guidewire in the delivery system.The radiopaque tip and valve capsule were observed to contain bent damage, which is consistent with damage during use.The inner shaft was noted to have an accordion damage, likely a result of the attempts to remove the guidewire.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the information received, the cause of the reported event could not conclusively be determined.However, an exception was initiated to evaluate the reported issue.The investigation identified the root cause as variability in guidewire coil behavior, which can interfere with flexnav delivery system crimps¿leading to advancement or removal issues.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.

• Brand Name: FlexNav Delivery System
• Common Device Name: 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 -178
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 50012948
• Report Number: 2135147-2026-05060
• Device Sequence Number: 9489481
• Product Code: NPT
• UDI-Device Identifier: 05415067031389
• UDI-Public: (01)05415067031389(17)271231(10)11238330
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2026

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
• Operator of Device: Health Professional
• Device Model Number: FNAV-DS-LG
• Device Catalogue Number: FNAV-DS-LG
• Device Lot Number: 11238330
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Circulo-XS
• Patient Sex: Unknown