MAUDE Adverse Event Report: ABBOTT MEDICAL FLEXNAV DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	FNAV-DS-SM
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation; the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2026, a 25mm navitor vision valve was selected for implant using a small flexnav delivery system (ds).Pre-implant balloon aortic valvuloplasty (pre-bav) was performed using a 20mm, non-abbott balloon.During the procedure, the valve was able to be implanted.It was confirmed that all the retainer tabs were released.Upon withdrawal of the ds, the tip caught on the valve leading it to be pulled up into the ascending aorta.The valve was surgically removed, and a new surgical valve was implanted.The patient remained hemodynamically stable throughout the procedure, and there was no clinically significant delay reported.The patient was in a stable condition.
Additional Manufacturer Narrative
An event of a difficult to remove was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Based on the available information and cine review, the cause for the reported difficult to remove could not be determined.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 25mm navitor vision valve was selected for implant using a small flexnav delivery system (ds).The patient has an aortic valve angle of 40 degrees.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed using a 20mm, non-abbott balloon.During the procedure, the valve was able to be implanted at a depth of 4-5mm.It was confirmed that all the retainer tabs were released.Upon withdrawal of the ds, the tip caught on the valve leading it to be pulled up into the ascending aorta.The valve was surgically removed, and a new surgical valve was implanted.The patient remained hemodynamically stable throughout the procedure, and there was no clinically significant delay reported.The patient was in a stable condition.

• 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: 24405930
• Report Number: 2135147-2026-01081
• Device Sequence Number: 18198556
• Product Code: NPT
• UDI-Device Identifier: 05415067031372
• UDI-Public: (01)05415067031372(17)270630(10)10974706
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/29/2026

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: 10974706
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2025
• 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: Female