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 Insert (1316); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6)2026, a 25 mm navitor vision valve was selected for implant using a small navitor loading system and a small flexnav delivery system.During preparation, loading was completed, the valve check was performed without issue, and no overcapture was observed.Following exchange of a 4.7 mm (0.185 inch) non-abbott sheath, the device was introduced via the transfemoral (tf) approach.The patient was reported to have tortuous anatomy; however, the tortuosity was not considered particularly severe.Resistance was encountered immediately upon insertion.The device was subsequently withdrawn, and it was observed that the tip of the valve capsule had folded back.The capsule tip was not split or torn.As a result, the 25 mm navitor vision valve, small flexnav delivery system, and small navitor loading system were replaced.The loading system was replaced because it became non-sterile after loading had been completed.No allegation of malfunction was reported against the small navitor loading system or the first 25 mm navitor vision valve.The replacement device was successfully implanted.The patient did not experience any issues or adverse events during or after the procedure and remained hemodynamically stable throughout the procedure.No clinically significant delay was reported.The healthcare professional stated that they did not believe the patient experienced adverse health consequences due to the performance of the product.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: 50180634
• Report Number: 2135147-2026-05411
• Device Sequence Number: 10035208
• Product Code: NPT
• UDI-Device Identifier: 05415067031372
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/24/2026

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-SM
• Device Catalogue Number: FNAV-DS-SM
• Device Lot Number: 11287544
• 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
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2026
• 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: Navitor Vision, NVRO-25
• Patient Sex: Unknown