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 Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An event of delivery system unable to advance due to eia calcification was reported.Also reported that the valve capsule was observed frayed upon withdrawing the delivery system.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported damage to valve capsule appears to be consistent with operational difficulties.However, the exact cause could not be determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6).2026, a 23mm navitor vision valve was selected for implant using a small flexnav delivery system (ds).Severe calcification in the common iliac artery (cia) and external iliac artery (eia) was observed.Cia was dilated using a 7.0/40, non-abbott balloon and eia by 6.0/40, non-abbott ballon using a plain old balloon angioplasty (poba) procedure.A 14 fr, non-abbott introducer sheath (is) was advanced with difficulty.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed using a 18mm, non-abbott balloon.During the procedure, the ds was unable to advanced due to the eia calcification.Upon withdrawing the ds, the tip of the valve capsule was observed to be frayed, and it was replaced with a new small flexnav ds.Wire was also noted to be replaced with another non-abbott wire, then the passage was successful.The valve was able to be implanted.The patient was hemodynamically stable throughout the procedure and there was no clinically significant delay reported.The patient was in a stable condition and subsequently discharged.

• 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 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24719329
• Report Number: 2135147-2026-01998
• Device Sequence Number: 6028023
• Product Code: NPT
• UDI-Device Identifier: 05415067031372
• UDI-Public: (01)05415067031372(17)270930(10)11093370
• 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
• Report Date (Section B): 03/27/2026

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: 11093370
• 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: 03/02/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2025
• 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
• Patient Sex: Unknown