MAUDE Adverse Event Report: ABBOTT MEDICAL FlexNav Delivery System; Aortic Valve, Prosthesis, Percutaneously Delivered

Model Number	FNAV-DS-LG
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Shock (2072); Vascular Dissection (3160)
Date of Event	05/21/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2026, a 27mm navitor vision valve was chosen for implant using a large flexnav delivery system.It was noted that the patient had a complex vascular access due to the significant degree of arterial calcification.A 14f sheath was inserted, followed by the delivery system.However, the delivery system was unable to be advanced.A 18f sheath was also used without success.Then a 20f sheath was used and advancement of the delivery system was successful.During advancement, a peripheral balloon for dilation was required due to the significant calcification of the pathway.The valve then successfully implanted.After the removal of the flexnav delivery system, during the withdrawal of the sheath, an iliac artery dissection was observed.A balloon inflation was performed at the site, while the vascular surgery team arrived.A covered stent was then implanted.During the subsequent course, the patient developed cardiac arrest secondary to hypovolemic shock.Resuscitation maneuvers were performed.However, they were unsuccessful and the patient passed away.
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.

• 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: 25524175
• Report Number: 2135147-2026-04142
• Device Sequence Number: 10746612
• Product Code: NPT
• UDI-Device Identifier: 05415067031389
• UDI-Public: (01)05415067031389(17)260731(10)10463950
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 09/25/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: FNAV-DS-LG
• Device Catalogue Number: FNAV-DS-LG
• Device Lot Number: 10463950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 06/16/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2024
• 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 VALVE
• Outcome Attributed to Adverse Event: Required Intervention; Death; Disability
• Patient Age: 85 YR
• Patient Sex: Unknown