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

Model Number	NVTR-25
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	06/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 25mm navitor valve was chosen for implant using an unknown delivery system.The annular dimensions of the native valve were perimeter: 66.4 mm, derived perimeter: 21.1 mm, annulus area 341.4 mm², left ventricular outflow tract (lvot) 18.6 mm, annulus diameter 18.8 mm, mean 20.9 mm / max ¿ 22.9 mm.The patient's aortic valve angle (av angle from 3mensio) was 51º.The procedure began with valve preparation without any complications.A pre-dilation was performed with a 18 mm non-abbott balloon.When the procedure was progressing normally, although the patient presented with hypotension before valve deployment.A vasopressor medication was administrated.After adjusting hemodynamic parameters, the valve was released using a temporary pacemaker (hr = 130 bpm).The implant depth at 80% was 4mm.After deployment, the implant appeared as expected, but following a cardiac cycle, the valve migrated into aorta and there was no interference from the delivery system.The physician snared the valve.A new 25mm navitor valve was prepared due to the abrupt hypotension.After several unsuccessful attempts by the team to cross the implanted valve with the guidewire, and given the patient's continued instability, the team opted for open-heart surgery.The patient was transferred by the hemodynamics team to the operating room.The surgery proceeded as expected, and the patient was transferred to the intensive care unit.The physician mentioned the cause of migration was patient¿s anatomy.
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of valve migration, and improper or incorrect procedure or method were reported.A returned device assessment could not be performed as the device was not returned for analysis.It was indicated that the cause of migration was patient¿s anatomy.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 migration could not be conclusively determined.It is possible that patient and procedural conditions, such as "little calcium" and implanting difficulties, contributed to the reported event; however, this cannot be confirmed.The reported improper or incorrect procedure or method was due to snaring the valve post-implant.The reported unexpected medical intervention and surgical intervention were result of case-specific circumstances: initially, as valve snared and a surgical removal of device was performed.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note the per the instruction for use (ifu), ¿post-implantation precautions: once the valve is fully deployed, repositioning and retrieval of the valve is not possible.Attempted retrieval (e.G., use of a guidewire, snare, or forceps) may cause aortic root, coronary artery, and/or myocardial damage.¿ since the ifu deviation was performed to prevent an adverse patient effect and there is no indication that the deviation caused any patient harm, a letter will not be sent.

• 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: 22331027
• Report Number: 2135147-2025-03421
• Device Sequence Number: 8411062
• Product Code: NPT
• UDI-Device Identifier: 05415067031587
• UDI-Public: (01)05415067031587(17)260521
• 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
• Device Explanted 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): 08/22/2025

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 Expiration Date: 05/21/2026
• Device Model Number: NVTR-25
• Device Catalogue Number: NVTR-25
• Device Lot Number: 9107313
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 85 KG