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	Hemorrhage/Blood Loss/Bleeding (1888); Vascular Dissection (3160)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 29mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).The patient has a tortuous anatomy.During the procedure, ds was not able to be advanced through the left iliac artery, so it was removed from the patient's anatomy.Non-abbott wire was exchanged to a different non-abbott wire.A new valve was selected for implant using a new ds and it was able to advance through left iliac artery with some exertion.The valve was able to be implanted at a depth of 2mm on the non-coronary cusp (ncc) and 3mm on the left-coronary cusp (lcc).Upon removal of the ds, bleeding was noted in the access site; the patient was transferred to the vascular operation room; vascular dissection was observed in the femoral then a left femoral artery repair was performed surgically.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported.Cardiology fellow believed the cause of bleeding to be due to the perclose device.The patient's condition is unknown.On follow-up, it was reported that the blood transfusion was administered and the patient had an extended hospitalization.The patient was discharged in a recovering condition.
Event or Problem Description
It was reported that on (b)(6) 2026, a 29mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).The patient has a tortuous anatomy.During the procedure, ds was not able to be advanced through the left iliac artery, so it was removed from the patient's anatomy.Non-abbott wire was exchanged to a different non-abbott wire.A new valve was selected for implant using a new ds and it was able to advance through left iliac artery with some exertion.The valve was able to be implanted at a depth of 2mm on the non-coronary cusp (ncc) and 3mm on the left-coronary cusp (lcc).Upon removal of the ds, bleeding was noted in the access site; the patient was transferred to the vascular operation room; vascular dissection was observed in the femoral then a left femoral artery repair was performed surgically.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported.Cardiology fellow believed the cause of bleeding to be due to the perclose device.The patient's condition is unknown.No additional information was provided.
Additional Manufacturer Narrative
An event of advancement difficulty through patient anatomy 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 specifications.Additionally, the lot was reviewed for similar complaints, and there is no indication of a lot-specific product issue.Based on the available information, the cause of the reported advancement difficulty through patient anatomy and subsequent vascular dissection and bleeding could not be conclusively determined.The reported hospitalization, unexpected medical intervention, and surgical intervention were results of case-specific circumstances as the dissection was repaired surgically and blood transfusion was required.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
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.

• 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: 50024277
• Report Number: 2135147-2026-05117
• Device Sequence Number: 9752419
• Product Code: NPT
• UDI-Device Identifier: 05415067031389
• UDI-Public: (01)05415067031389(17)271031(10)11134890
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2026

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-LG
• Device Catalogue Number: FNAV-DS-LG
• Device Lot Number: 11134890
• 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: 06/29/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 217 LB
• Patient Race: White