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); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Tachycardia (2095)
Date of Event	04/29/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.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 navitor valve was selected for implant using a small flexnav delivery system (ds).The patient had extremely severe calcified aorta & bi-lateral iliac arteries.Prior to the implant, the patient was in a stable condition.The patient did not have a history of right branch bundle block (rbbb), left bundle branch block (lbbb) or 1st/2nd degree atrioventricular (av) block.Pre-implant balloon valvuloplasty (pre-bav) was performed using an unspecified balloon.The patient was developed with ventricular tachycardia (vt) and required defibrillation to become stable.During the procedure, the ds couldn't pass through both the sides of iliac arteries.It was also reported that several percutaneous transluminal angioplasties (pta) were performed; however, the difficulty remained persisted.The patient became hypotensive then developed with cardiac arrest and iliac artery perforation.The procedure was aborted and the patient was sent to intensive care unit (icu) for further management, but the patient could not be recovered and pronounced to be deceased.
Additional Manufacturer Narrative
An event of an advancement difficulty through patient, tachycardia, perforation, hypotension, cardiac arrest, and death were reported.The device was returned to abbott for investigation and the valve capsule and inner shaft contained bent damages, consistent with damage incurred during use.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing 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 and medical review, the cause for the reported advancement difficulty is likely related to challenging patient anatomy including tight iliac arteries on both sides.The reported tachycardia, cardiac arrest, perforation, and hypotension are likely cascading effects from the event.An exact cause for the reported death cannot be conclusively determined; however, this case is considered a procedural mortality due to vascular complications in a patient with known peripheral vascular disease.Unexpected medical interventions were a result of case specific circumstances, as a blood transfusion and several percutaneous transluminal angioplasty (pta) were performed.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2026, a navitor valve was selected for implant using a large flexnav delivery system (ds).The patient had extremely severe calcified aorta and bi-lateral iliac arteries.Prior to the implant, the patient was in a stable condition.The patient did not have a history of right branch bundle block (rbbb), left bundle branch block (lbbb) or1st/2nd degree atrioventricular (av) block.Pre-implant balloon valvuloplasty (pre-bav) was performed using a 25 mm, unspecified balloon.The patient was developed with ventricular tachycardia (vt) and required defibrillation to become stable.During insertion, the patient was developed with cardiac arrest and iliac artery perforation.During the procedure, the ds couldn't pass through both the sides of iliac arteries.It was also reported that several percutaneous transluminal angioplasty (pta) were performed; however, the difficulty remained persisted.The patient was reported to be developed with hypotension, and condition had worsened leading to termination of the procedure then the patient was sent to intensive care unit (icu) for further management, but the patient could not be recovered and pronounced to be deceased.

• 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: 25236955
• Report Number: 2135147-2026-03434
• Device Sequence Number: 15852341
• Product Code: NPT
• UDI-Device Identifier: 05415067031389
• UDI-Public: (01)05415067031389(17)271231(10)11197910
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 07/21/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: FNAV-DS-LG
• Device Catalogue Number: FNAV-DS-LG
• Device Lot Number: 11197910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 07/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2026
• 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: Death
• Patient Sex: Unknown