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

Model Number	FNAV-DS-SM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Vascular Dissection (3160)
Date of Event	02/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of vascular dissection which subsequently led to occlusion was reported.A returned device assessment could not be performed as the device was not returned for analysis.Information from field indicated that it was believed inserting the flexnav delivery system into the small vessel caused a vascular dissection, which subsequently led to an occlusion.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.The medical intervention was result of a percutaneous treatment performed.There were no related complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
Clinical information: (b)(6) - vista nova study, patient site (b)(6).It was reported that on (b)(6) 2026, a 25mm navitor vision valve was chosen for implant using a small flexnav delivery system.A pre-implant balloon valvuloplasty was done with a 22mm non-abbott balloon.The valve was successfully implanted.It was believed that inserting the flexnav delivery system into the small vessel caused a vascular dissection, which subsequently led to an occlusion.For treatment, a percutaneous old balloon angioplasty (poba) was performed.

• 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: 24769531
• Report Number: 2135147-2026-02102
• Device Sequence Number: 21144295
• Product Code: NPT
• UDI-Device Identifier: 05415067031372
• UDI-Public: (01)05415067031372(17)270831(10)11065192
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 04/02/2026

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 Model Number: FNAV-DS-SM
• Device Catalogue Number: FNAV-DS-SM
• Device Lot Number: 11065192
• 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: 03/13/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown