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

Model Number	NVTR-27
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Migration or Expulsion of Device (1395); Off-Label Use (1494)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Aortic Valve Insufficiency/ Regurgitation (4450); Coronary obstruction/occlusion (4871)
Date of Event	09/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.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 27mm navitor valve was chosen for implantation utilizing a large flexnav delivery system.Aortic angle was 63 degrees.Sufficient calcium present for anchoring.Patient presented with bicuspid aortic valve, significant leaflet calcification, and a calcium block between the left and right sinuses.Pre-dilatation was performed with a 22mm balloon.Navitor valve was advanced.At 80% deployment, the valve was under expanded at a depth of 5mm.Under expansion thought to be due to excess calcium and bicuspid anatomy.It was decided to release in a lower position with a planned post dilatation.After deployment at 3mm the valve migrated towards aorta.All tabs had released and guidewire was at midventricular position.Post dilatation was performed but following this, developed aortic insufficiency and cardiac arrest.Chest compressions were performed.A second 27mm navitor valve was then implanted valve in valve with a new large flexnav, but the patient remained in cardiac arrest and chest compressions continued.It was then decided to place the patient on cardiopulmonary bypass (cbp).After this, it was discovered that the left coronary artery was partially obstructed by the first valve.A stent was placed and the patient began showing improvement.The procedure concluded and patient was transferred to icu with ecmo support.Left ventricular function normalized, the valve was functioning normally with a gradient of 13mmhg.Physician thought the migration was due to the bicuspid anatomy.
Event or Problem Description
It was reported that on (b)(6) 2025, a 27mm navitor valve was chosen for implantation utilizing a large flexnav delivery system.Aortic angle was 63 degrees.Sufficient calcium present for anchoring.Patient presented with bicuspid aortic valve, significant leaflet calcification, and a calcium block between the left and right sinuses.Pre-dilatation was performed with a 22mm balloon.Navitor valve was advanced.At 80% deployment, the valve was under expanded at a depth of 5mm.Under expansion thought to be due to excess calcium and bicuspid anatomy.It was decided to release in a lower position with a planned post dilatation.After deployment at 3mm the valve migrated towards aorta.All tabs had released and guidewire was at midventricular position.Post dilatation was performed but following this, developed aortic insufficiency and cardiac arrest.Chest compressions were performed.A second 27mm navitor valve was then implanted valve in valve with a new large flexnav, but the patient remained in cardiac arrest and chest compressions continued.It was then decided to place the patient on cardiopulmonary bypass (cbp).After this, it was discovered that the left coronary artery was partially obstructed by the first valve.A stent was placed and the patient began showing improvement.The procedure concluded and patient was transferred to icu with ecmo support.Left ventricular function normalized, the valve was functioning normally with a gradient of 13mmhg.Physician thought the migration was due to the bicuspid anatomy.The patient was reported to now be off ecmo and progressing well.
Additional Manufacturer Narrative
An event of incomplete stent opening, valve migration, aortic valve insufficiency, cardiac arrest and obstruction coronary artery obstruction was reported.A returned device assessment could not be performed as the device remains implanted and 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, the cause of the reported coronary artery obstruction is likely related to the valve migration.However, the cause of the reported valve migration and incomplete stent opening could not be conclusively determined.Patient condition (bicuspid aortic valve, significant leaflet calcification, and a calcium block between the left and right sinuses) appears to have contributed to the reported event.The cause of the reported cardiac arrest and aortic valve insufficiency could not be conclusively determined.The reported off-label use was related to the use of the navitor on a bicuspid aortic valve.The reported surgical and unexpected medical intervention were results of case-specific circumstances as post-implant valvuloplasty was performed to address the incomplete stent opening, resuscitation was performed due to cardiac arrest, and another valve was implanted due to the valve migration (valve-in-valve).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, ¿contraindications: the valve is contraindicated for patients with any leaflet configuration other than tricuspid.¿.

• 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: 23174494
• Report Number: 2135147-2025-05510
• Device Sequence Number: 13171496
• Product Code: NPT
• UDI-Device Identifier: 05415067031594
• UDI-Public: (01)05415067031594(17)270807
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 11/17/2025

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: NVTR-27
• Device Catalogue Number: NVTR-27
• Device Lot Number: 10490949
• 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: 09/04/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2024
• 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; Disability
• Patient Age: 60 YR
• Patient Sex: Female