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 Advance (2920)
Health Effect - Clinical Codes	Pain (1994); Vascular Dissection (3160)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) vista nova, patient site id: (b)(6).It was reported that on (b)(6) 2026, a 23mm navitor valve with radiopaque markers was chosen for implant with a small flexnav delivery system (ds).During procedure, the small flexnav ds could not pass through the right common iliac artery (cia) due to severe calcification.A wire exchange was performed after 7mm plain old balloon angioplasty (poba) with a non-abbott balloon.The small flexnav ds was able to pass, however, the valve could not cross the sino-tubular junction due to severe calcification, as well.A snare was used to assist with delivery and successfully implant the valve.Patient remained hemodynamically stable throughout the procedure.Post-procedure after returning to the ward, patient complained of back pain.Computed tomography demonstrated an acute type b aortic dissection extending from the distal aortic arch to the abdominal aorta.The physician attributed the cause of the aortic dissection related to difficulty of advancing the flexnav ds through patient anatomy.Prolonged hospitalization was reported.Patient was administered medication.
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: 50820166
• Report Number: 2135147-2026-06333
• Device Sequence Number: 10713097
• Product Code: NPT
• UDI-Device Identifier: 05415067031372
• UDI-Public: (01)05415067031372(17)280630(10)11506136
• 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,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FNAV-DS-SM
• Device Catalogue Number: FNAV-DS-SM
• Device Lot Number: 11506136
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2026
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 79 LB