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

Model Number	FNAV-DS-LG
Medical Device Problem Codes	Retraction Problem (1536); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 35 mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).The patient had a prior medical history of coronary artery bypass graft (cabg), heart failure, hypertension, diabetes, ischemic heart disease, parkinson¿s disease, gastritis, and anemia.During device preparation, the valve was loaded by an abbott employee.No issues were reported with retracting the valve into the delivery system or leading the retainer tabs into the retainer receptacle.The valve was observed to enter the capsule slowly during loading.It was reported that loading was harder than usual, but no excess force was required to turn the resheath wheel.The deploy/resheath wheel did not reach the end of travel, and an approximately 4-5 mm gap remained.The gap was subsequently closed using the micro-adjustment wheel.The procedure was performed under general anesthesia.The patient was reported to have calcified femoral vessels, and the heart team elected to obtain vascular access via surgical cutdown.A 14 fr non-abbott introducer sheath was used with a 26 mm non-abbott balloon for pre-dilatation and was subsequently removed.The ds was then used without a sheath.During the initial deployment attempt, the ds had a tendency to dive into the left ventricular outflow tract (lvot).The operator applied slight pull on the system, causing the valve to acutely migrate into the aortic sinuses.Resheathing at that position was not feasible.The ds was gently retracted into the ascending aorta.Subsequent attempts to resheath the valve using both the deployment wheel and micro-adjustment wheel were unsuccessful.The valve capsule was observed to be bent and demonstrated severe non-coaxiality.To bypass the deformation angle, the system was retracted further; however, the resheathing attempt remained unsuccessful, and structural damage to the delivery capsule was visualized.As a result, the decision was made to deploy the valve in the aortic arch.It was reported that the valve was not resheathed more than two times.As previously reported, an attempt was made to use the micro-adjustment wheel during the resheathing attempt; however, it did not work.Following deployment in the arch, the anesthesia team noted a transient decrease in right radial artery pressure secondary to partial ostial obstruction of the brachiocephalic artery by the valve.A snare kit was introduced to mobilize the valve.The valve was successfully repositioned further down the aortic arch, resulting in immediate normalization of the right radial artery pressure.A new 35 mm navitor vision valve was subsequently loaded into a new large flexnav delivery system.The second tavi deployment was performed successfully on the first attempt with optimal positioning.The second valve was not implanted within the first valve (not valve-in-valve).Final echocardiographic and angiographic assessments reportedly demonstrated no paravalvular leak (pvl) and a maximum transvalvular gradient of 5 mmhg.The healthcare professional stated that they did not believe the patient experienced adverse health consequences due to the performance of the product.No clinically significant delay was reported, and the patient remained stable throughout the procedure.The patient's status was reported as discharged.
Additional Manufacturer Narrative
The device is not returning for evaluation.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: 50180907
• Report Number: 2135147-2026-05423
• Device Sequence Number: 21297175
• Product Code: NPT
• UDI-Device Identifier: 05415067031389
• UDI-Public: (01)05415067031389(17)280131(10)11281307
• Combination Product (Y/N): N
• Initial Reporter Country: GG
• 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): 08/07/2026

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-LG
• Device Catalogue Number: FNAV-DS-LG
• Device Lot Number: 11281307
• 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: 07/13/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2026
• 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: FlexNav, FNAV-DS-LG; Navitor Vision, NVRO-35
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 176 LB