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 Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	03/03/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2026, a 25mm navitor vision valve was selected for implant using a small flexnav delivery system (ds).Prior to the procedure, the patient was in a stable condition.The patient had severe calcified anatomy in the ascending and abdominal aorta.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed using a 17mm, non-abbott balloon.During the procedure, the ds was unable to advance the sinotubular junction (stj) calcium deposits, so it was retracted down to the abdominal aorta.During the time of discussion on continuing with the next steps, the patient became hypotensive and a cardiopulmonary resuscitation (coded) was performed, and medication (unspecified) was administered, subsequently the patient was pronounced to be deceased.The physician stated that he does not believe it was a product issue other than not being able to cross calcified stj.Additionally, he stated that the adverse consequences were due to patient's anatomy, frailty, and being high risk for the procedure.The official cause of death was circulatory collapse.
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.
Additional Manufacturer Narrative
An event of difficult to advance 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 issue could not be conclusively determined.It is possible procedural and/or patient circumstances contributed to the reported advancement difficulty; however, this cannot be confirmed.The reported unexpected medical interventions are due to case specific circumstances, as a cpr was performed and medication was provided.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2026, a 25 mm navitor vision valve was selected for implant using a small flexnav delivery system (ds).Prior to the procedure, the patient was in a stable condition.The patient had severe calcified anatomy in the ascending and abdominal aorta.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed using a 17 mm, non-abbott balloon.During the procedure, the ds was unable to advance the sinotubular junction (stj) calcium deposits, so it was retracted down to the abdominal aorta.During the time of discussion on continuing with the next steps, the patient became hypotensive and a cardiopulmonary resuscitation (coded) was performed, and medication (unspecified) was administered, subsequently the patient was pronounced to be deceased.The physician stated that he does not believe it was a product issue other than not being able to cross calcified stj.Additionally, he stated that the adverse consequences were due to patient's anatomy, frailty, and being high risk for the procedure.The official cause of death was circulatory collapse.

• 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: 24720635
• Report Number: 2135147-2026-02010
• Device Sequence Number: 6121235
• Product Code: NPT
• UDI-Device Identifier: 05415067031372
• UDI-Public: (01)05415067031372(17)270531(10)10902420
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/06/2026

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-SM
• Device Catalogue Number: FNAV-DS-SM
• Device Lot Number: 10902420
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2025
• 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-25
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female