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

Model Number	FNAV-DS-LG
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
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 29 mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).The patient has a prior medical history of carotid artery stenosis, and a vascular graft was placed in the aorta for an unknown reason.The patient also had a horizontal anatomy with an angulation of 71 degrees.Transfemoral access was selected as the access site.During the procedure, the ds was difficult to be inserted and unable to be advanced, and the valve capsule part was reported to be flared.A new 29 mm, navitor vision valve was selected for implant using a large flexnav ds.It was unable to be advanced, and a kink was observed and it was removed from the patient's anatomy.A third new 29 mm, navitor valve was selected for implant using a third large flexnav ds.It was unable to be recaptured so it was pulled into descending aorta, and a micro-adjustment wheel was used.The valve was able to be implanted successfully at a depth of 6 mm both on the non-coronary cusp (ncc) and left-coronary cusp (lcc).The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported.Post-procedure, neurosurgeon confirmed that cerebral infarction had occurred.The patient had experienced loss of consciousness (delayed awakening from general anesthesia), but consciousness has now been regained.The patient is currently hospitalized and is receiving medication.Extracorporeal membrane oxygenation (ecmo) was placed for an unknown reason.

• 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: 25167103
• Report Number: 2135147-2026-03220
• Device Sequence Number: 13307582
• Product Code: NPT
• UDI-Device Identifier: 05415067031389
• UDI-Public: (01)05415067031389(17)270831(10)11207630
• 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): 06/30/2026

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-LG
• Device Catalogue Number: FNAV-DS-LG
• Device Lot Number: 11207630
• 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: 04/17/2026
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NVRO-29.
• Patient Age: 81 YR
• Patient Sex: Male