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

Model Number	FNAV-DS-LG
Medical Device Problem Codes	Off-Label Use (1494); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6)2026, a 35mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).The patient has a prior medical history of being implanted with a bi-ventricular pacemaker and 27mm non-abbott surgical valve.During the procedure, on the initial attempt, the valve was in deeper position, and it was attempted for a partial recapture then the valve capsule migrated above the annulus requiring a full recapture of the valve.Ds was retracted back into the descending aorta, and multiple rotations were made with the micro-adjustment wheel.However, it was unable to fully recapture the valve, and the ds was removed from the patient's anatomy.A new 35mm, navitor vision valve was replaced by using a new large flexnav ds resulting in successful implantation.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported.
Additional Manufacturer Narrative
The device was received.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: 50818507
• Report Number: 2135147-2026-06300
• Device Sequence Number: 10677166
• Product Code: NPT
• UDI-Device Identifier: 05415067031389
• UDI-Public: (01)05415067031389(17)280229(10)11304666
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 11304666
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2026
• 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
• Patient Age: 62 YR
• Patient Sex: Male