MAUDE Adverse Event Report: ABBOTT MEDICAL FlexNav Delivery System; Aortic Valve, Prosthesis, Percutaneously Delivered

Model Number	FNAV-DS-LG
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, a 29mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).Access site was selected as femoral artery.During the procedure, the ds was attempted to pass through the femoral artery and at the end of the bifurcation of superior common iliac artery it was unable to be advanced.Following several attempts, the ds was removed from the patient's anatomy, and the external sheath was re-inserted.Upon inspection, the ds's valve capsule around the radiopaque marker bank was observed to be damaged and the transition between the marker band and radiopaque tip was rough and also damaged.A second 29mm, navitor vision valve was selected for implant using a large flexnav ds.A non-abbott balloon was used as a dilation.The system was introduced and attempted to advance but resulted without success.The case was decided to be aborted.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported.The patient was in a stable condition and subsequently discharged.
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

• 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: 25413895
• Report Number: 2135147-2026-03812
• Device Sequence Number: 18507984
• Product Code: NPT
• UDI-Device Identifier: 05415067031389
• UDI-Public: (01)05415067031389(17)270831(10)11036883
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2026

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: 11036883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Supplement Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 06/05/2026
• Supplement Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2025
• 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: NVRO-29; NVRO-29.
• Patient Age: 80 YR
• Patient Sex: Female