MAUDE Adverse Event Report: ABBOTT MEDICAL NAVITOR TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	NVTR-29
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	11/05/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2025, a 29mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).The patient had a prior medical history of severe aortic stenosis, coronary artery disease managed by unknown medications, diabetes mellitus, and previously documented a left ventricular ejection fraction of approximately 40 percent.The patient had arrived in a stable condition prior to the procedure.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed using a 23x40mm, non-abbott balloon.Annular expansion remained insufficient and resistance persisted.During the procedure, difficulty in advancing the ds through the native annulus was noted.A second pre-bav with a larger balloon (25 mm) was then performed, which allowed the ds to advance.At the initial position, the fluoroscopic image revealed aortic regurgitation.It was noted that the valve remained inside the capsule at this time.The patient developed severe hemodynamic instability and it was decided to continue the valve deployment.While the valve was partially deployed at 80 percent, the patient presented with low bleed pressure.Chest compressions, intubation and drug administration was performed to resolve the event.However, the patient did not show a positive clinical outcome, so it was decided to recapture the valve and retract the ds to the aortic arch to improve outcomes of the resuscitation maneuvers.Despite resuscitation efforts, the patient went into cardiac arrest and could not recover.On (b)(6) 2025, the patient was pronounced deceased.The implanter considered the event to be related to the patient¿s condition and procedural complications and did not attribute it to the performance of the device.
Event or Problem Description
It was reported that on (b)(6) 2025, a 29mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).The patient had a prior medical history of severe aortic stenosis, coronary artery disease managed by unknown medications, diabetes mellitus, and previously documented a left ventricular ejection fraction of approximately 40 percent.The patient had arrived in a stable condition prior to the procedure.The patient¿s aortic valve angle was horizontal measured to be 56 degrees and had a tortuous anatomy.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed using a 23x40mm, non-abbott balloon.Annular expansion remained insufficient and resistance persisted.During the procedure, difficulty in advancing the ds through the native annulus was noted.A second pre-bav with a larger balloon (25 mm) was then performed, which exceeds the minimum annulus diameter, but allowed the ds to advance.At the initial position, the fluoroscopic image revealed aortic regurgitation.It was noted that the valve remained inside the capsule at this time.The patient developed severe hemodynamic instability and it was decided to continue the valve deployment.While the valve was partially deployed at 80 percent, the patient presented with low bleed pressure.Chest compressions, intubation and drug administration was performed to resolve the event.However, the patient did not show a positive clinical outcome, so it was decided to recapture the valve and retract the ds to the aortic arch to improve outcomes of the resuscitation maneuvers.Despite resuscitation efforts, the patient went into cardiac arrest and could not recover.On (b)(6) 2025, the patient was pronounced deceased.The implanter considered the event to be related to the patient¿s condition and procedural complications and did not attribute it to the performance of the device.
Additional Manufacturer Narrative
An event of hypotension, aortic regurgitation, cardiac arrest and death 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.Based on the available information and medical review, the cause of death appears to be acute severe aortic insufficiency secondary to valvuloplasty in a patient with compromised left ventricular function (ef 40%).The cause of the reported hypotension and cardiac arrest are likely cascading effects of the acute severe aortic insufficiency.The reported unexpected medical intervention was a result of case-specific circumstances as the patient was intubated, medication was administered, and resuscitation efforts were made.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.It should be noted that per the instruction for use (ifu), ¿pre-implantation precautions: balloon aortic valvuloplasty (bav) of the native aortic valve is recommended prior to delivery system insertion.The balloon size chosen should be appropriate, not exceeding the minimum diameter of the native aortic annulus as assessed by ct imaging to minimize risk of annular rupture and not undersized to minimize risk of stent under-expansion which could lead to paravalvular leak (pvl) or device migration.¿ code removed: medical device problem code: 2993.

• Brand Name: NAVITOR TRANSCATHETER AORTIC VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23663043
• Report Number: 2135147-2025-07033
• Device Sequence Number: 12973168
• Product Code: NPT
• UDI-Device Identifier: 05415067031600
• UDI-Public: (01)05415067031600(17)260827
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 02/25/2026

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 Expiration Date: 08/27/2026
• Device Model Number: NVTR-29
• Device Catalogue Number: NVTR-29
• Device Lot Number: 9251131
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2023
• 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: NVTR-29.
• Outcome Attributed to Adverse Event: Required Intervention; Disability; Death
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 65 KG