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

Model Number	NVTR-27
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2025 a 27mm navitor vision valve was selected for an endo-bentall procedure.The valve was sutured into a modified non-abbott endo-graft.During the procedure the physician accidentally deployed the valve in the sinus of valsalva (sov).The patient was transferred to cardiac surgery to remove the device and repair the aortic root.The patient status was hospitalization.
Additional Manufacturer Narrative
The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of improper valve deployment during an off-label endo-bentall procedure 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.Based on the available information, the cause of the reported use of device problem appears to be procedural circumstances.The reported surgical intervention was a result of case-specific circumstances as the device was removed surgically and aortic root repair was performed.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 (ifu), ¿pre-implantation precautions: the safety and effectiveness of the navitor¿ valve and flexnav¿ delivery system have not been evaluated in the following patient populations: ¿ congenital unicuspid or bicuspid valve, or any leaflet configuration other than tricuspid¿.
Event or Problem Description
It was reported on (b)(6) 2025 a 27mm navitor vision valve was selected for an endo-bentall procedure.The valve was sutured into a modified non-abbott endo-graft.During the procedure the physician accidentally deployed the valve in the sinus of valsalva (sov).The patient was transferred to cardiac surgery to remove the device and repair the aortic root.The patient status was hospitalization.

• 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: 22994236
• Report Number: 2135147-2025-05076
• Device Sequence Number: 9620059
• Product Code: NPT
• UDI-Device Identifier: 05415067031594
• UDI-Public: (01)05415067031594(17)251113
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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: 11/13/2025
• Device Model Number: NVTR-27
• Device Catalogue Number: NVTR-27
• Device Lot Number: 8785255
• 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: 08/15/2025
• Supplement Date Received by Manufacturer: 10/18/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COOK ZENITH ENDOGRAFT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female