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

Catalog Number	NVTR-23
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
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 on (b)(6) 2024, a 23mm navitor transcatheter aortic valve (serial: (b)(6)) was chosen for implantation utilizing a small flexnav delivery system.Pre-balloon valvuoplasty was performed with a 16mm atlas gold balloon.The navitor valve was then delivery to the annulus.When checking the commisural alignment with overlapping projection of fluoroscopy, the aortic end of the valve stent was distorted.It was suspected the stent struts were twisted inside the valve capsule.There was no torque applied to the delivery system.The navitor was recaptured and removed.A replacement 23mm navitor and small flexnav delivery system were used to complete the procedure successfully with good result.There were no patient consequences reported.
Additional Manufacturer Narrative
An event of material deformation of stent post reported.A returned device inspection\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.The investigation was unable to determine the cause for the reported material deformation of stent post.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 20695114
• Report Number: 2135147-2024-05778
• Device Sequence Number: 3714949
• Product Code: NPT
• UDI-Device Identifier: 05415067031570
• UDI-Public: (01)05415067031570(17)250116(10)8328696
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 01/17/2025

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: 01/16/2025
• Device Catalogue Number: NVTR-23
• Device Lot Number: 8328696
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 01/12/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2022
• 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
• Patient Age: 80 YR
• Patient Sex: Female