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

Catalog Number	NVTR-23
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2024, a 23mm navitor valve was selected for implant.The patient had moderate calcification and an aortic annulus size of: perimeter: 65.9 mm, perimeter derived ø: 21.0 mm, area: 341.9 mm², area derived ø: 20.9 mm, min ø: 20.0 mm, max ø: 22.2 mm, average ø: 21.1 mm, eccentricity: 0.10.The aortic valve angle was 50.A pre-dilation was performed with a 20mm x 4.5cm non-abbott balloon.During the procedure, the valve was positioned and deployed at 3mm.There was sufficient calcium to allow anchoring of the device.The device ended up migrating into the ascending aorta due to the delivery system interacting with the valve.There was no obstruction of blood flow from the migration.A second 23mm navitor valve was taken and successfully implanted below the valve without complications.There was no pvl post implant.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of migration or expulsion of device in aortic direction 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, a review of the complaint history identified no similar incidents reported from this lot.Based on the information received, the reported device migration appears to be related to procedural conditions.The surgical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2024, a 23mm navitor valve was selected for implant.The patient had moderate calcification and an aortic annulus size of: perimeter: 65.9 mm, perimeter derived ø: 21.0 mm, area: 341.9 mm², area derived ø: 20.9 mm, min ø: 20.0 mm, max ø: 22.2 mm, average ø: 21.1 mm, eccentricity: 0.10.The aortic valve angle was 50.A pre-dilation was performed with a 20mm x 4.5cm non-abbott balloon.During the procedure, the valve was positioned and deployed at 3mm.There was sufficient calcium to allow anchoring of the device.The device ended up migrating into the ascending aorta due to the delivery system interacting with the valve.There was no obstruction of blood flow from the migration.A second 23mm navitor valve was taken and successfully implanted below the valve without complications.There was no pvl post implant.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.

• 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: 20471980
• Report Number: 2135147-2024-05125
• Device Sequence Number: 12630420
• Product Code: NPT
• UDI-Device Identifier: 05415067031570
• UDI-Public: (01)05415067031570(17)261017(10)10077546
• Combination Product (Y/N): N
• 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): 01/29/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: NVTR-23
• Device Lot Number: 10077546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 01/25/2025
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2023
• 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: 69 YR
• Patient Sex: Female