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

Model Number	FNAV-DS-SM
Medical Device Problem Codes	Difficult to Remove (1528); Retraction Problem (1536); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Vascular Dissection (3160)
Date of Event	08/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 23 navitor vision valve was selected for implant using a small flexnav delivery system (ds) due to the patient's anatomy with severely calcified aortic valve with tapered left ventricular outflow tract (lvot) and smaller sinus of valsalva (sov).Pre-implant balloon aortic valvuloplasty (pre-bav) was performed by using an 18mm, non-abbott balloon.The valve was loaded and check with x-ray.During the procedure, the physicians used rotation move to make insertion swifter and some resistance was experienced with the flexnav ds.At 80 percent, the valve appeared to be constrained therefore a partial resheath was performed and it was observed that the nose cone was not recaptured completely.On the second attempt, the valve expanded comparatively better but significant paravalvular leak (pvl) was observed then the physician's deemed that the 23mm valve to be undersized and a second 25mm, navitor vision valve was decided to be replaced using a new small flexnav ds.Once the loading was completed, 23mm, navitor vision valve was attempted for recapture but once again the retraction issue persisted while the nose cone being exposed.Ds was retracted into the descending aorta to improve the coaxial alignment.Micro-adjustment wheel was used several times including macro-buttons.At this moment, the valve capsule was observed to be crumpled/wrinkled.It was attempted to remove the ds from the patient's anatomy; however, removal was challenging because the crumpled portion of the ds was too large to pass through the femoral arteries.Upon discussion, it was decided to deploy in the descending aorta.Ds was able to be removed with significant pulling, pushing and rotating.No significant bleeding was observed, and it was attempted to insert the second 25mm, navitor valve with the new small flexnav ds.The ds was not able to be inserted, subsequently a femoral artery dissection was identified.The patient was received general anesthesia (ga) then the artery was implanted with a stent; two units of blood were administered.The procedure was noted to be abandoned.In the physician's opinion wrinkled part of the flexnav ds was thought to be the cause of the femoral artery dissection.On the following day, the patient was extubated and in a recovering condition.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.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: 50817858
• Report Number: 2135147-2026-06295
• Device Sequence Number: 16007132
• Product Code: NPT
• UDI-Device Identifier: 05415067031372
• UDI-Public: (01)05415067031372(17)280430(10)11395001
• 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,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FNAV-DS-SM
• Device Catalogue Number: FNAV-DS-SM
• Device Lot Number: 11395001
• Was Device Available for Evaluation?: No
• 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: 05/05/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown