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

Catalog Number	NVTR-25
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Perivalvular Leak (1457); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
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 a 25mm navitor transcathetor aortic valve was selected for implant on (b)(6) 2024 for a valve-in-valve procedure using a small flexnav delivery system.The initial valve was implanted approximately 10 years ago.The patient's annular perimeter derived diameter was measured at 21.8m and the left ventricle outflow tract diameter was 21.7mm.Pre-dilation was performed with a 20mm balloon.The starting implant depth was 4-5mm from the non-coronary cusp (ncc).Approximately 1 minute after the valve was released from the delivery cable, the valve was observed to have risen 1-2 mm towards the aorta and remained shallow but was functioning as intended with leaflets captured.On (b)(6) 2024 an ultrasound was performed and a trace to mild perivalvular leak was detected.
Additional Manufacturer Narrative
The device was not returned for analysis.An event of off-label use, migration, and perivalvular leak (pvl) was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The provided imaging was reviewed by an abbott senior director of medical affairs.Based on all available information, the reported off-label use is related to the device being used for a valve-in-valve procedure.Causes for the migration and pvl could not be conclusively determined.The reported unexpected medical intervention and surgery were the result of case-specific circumstances.
Event or Problem Description
It was reported that a 25mm navitor transcathetor aortic valve was selected for implant on (b)(6)2024 for a valve-in-valve procedure using a small flexnav delivery system.The initial valve was implanted approximately 10 years ago.The patient's annular perimeter derived diameter was measured at 21.8m and the left ventricle outflow tract diameter was 21.7mm.Pre-dilation was performed with a 20mm balloon.The starting implant depth was 4-5mm from the non-coronary cusp (ncc).Approximately 1 minute after the valve was released from the delivery cable, the valve was observed to have risen 1-2 mm towards the aorta and remained shallow but was functioning as intended with leaflets captured.On 04 december 2024 an ultrasound was performed and a trace to mild perivalvular leak was detected.

• 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: 21028172
• Report Number: 2135147-2024-06641
• Device Sequence Number: 9156225
• Product Code: NPT
• UDI-Device Identifier: 05415067031587
• UDI-Public: (01)05415067031587(17)260726(10)9197711
• 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: 2024
• 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): 03/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/26/2026
• Device Catalogue Number: NVTR-25
• Device Lot Number: 9197711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2023
• 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: Other
• Patient Sex: Unknown