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

Model Number	NVTR-25
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that on (b)(6) 2025, a 27mm navitor valve was selected for implant using a large flexnav delivery system (ds).The patient had a tri-leaflet aortic annulus with severe calcification and had anatomical measurements of was: annulus diameter of 23.6 mm, annulus area of 428.2 mm², and annulus perimeter of 74.3 mm.During the procedure, a pre-bav was performed using a 22x40mm balloon.When the valve was be then attempted, it was found that there was non-uniform expansion (nue).To try and mitigate this, attempts were made to deploy the device slower and also deeper, but was unsuccessful.The device was removed from the patient.The same pre-bav balloon and 27mm navitor were used again, the valve was positioned at 5mm, but the nue remained.The device was removed and a 25mm navitor was implanted instead at a depth of 5mm.There was no nue, but there was moderate pvl.A post-bav was performed using a 24x40mm balloon and the pvl was reduced to mild.The patient ended up experiencing left bundle branch block as well.The procedure was completed without a clinically significant delay and the patient remained hemodynamically stable throughout the procedure.The patient was monitored in the hospital for 7 days.There were no adverse patient consequences.
Event or Problem Description
It was reported that on (b)(6) 2025, a 27mm navitor valve was selected for implant using a large flexnav delivery system (ds).The patient had a tri-leaflet aortic annulus with severe calcification and had anatomical measurements of was: annulus diameter of 23.6 mm, annulus area of 428.2 mm², and annulus perimeter of 74.3 mm.During the procedure, a pre-bav was performed using a 22x40mm balloon.When the valve was be then attempted, it was found that there was non-uniform expansion (nue).To try and mitigate this, attempts were made to deploy the device slower and also deeper but was unsuccessful.The device was removed from the patient.The same pre-bav balloon and 27mm navitor were used again, the valve was positioned at 5mm, but the nue remained.The device was removed and a 25mm navitor was implanted instead at a depth of 5mm.There was no nue, but there was moderate pvl.A post-bav was performed using a 24x40mm balloon and the pvl was reduced to mild.The patient ended up experiencing left bundle branch block as well.The procedure was completed without a clinically significant delay and the patient remained hemodynamically stable throughout the procedure.The patient was monitored in the hospital for 7 days.There were no adverse patient consequences.
Additional Manufacturer Narrative
An event of perivalvular leak and heart block was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.It was indicated that it was found that there was non-uniform expansion (nue).To try and mitigate this, attempts were made to deploy the device slower and also deeper, but was unsuccessful.A new device was implanted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications, including specification for radial force.From the imaging received the reported events cannot be assessed.Based on the information received, the cause of the reported perivalvular leak could not be conclusively determined.The reported patient effects of heart block could not be determined.Also, it is possible due to procedural conditions (post-dilation aortic valvuloplasty (bav)); however, this cannot be confirmed.The reported unexpected medical intervention was a result of case-specific circumstances as a valvuloplasty was performed.

• 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: 22482562
• Report Number: 2135147-2025-03795
• Device Sequence Number: 8668686
• Product Code: NPT
• UDI-Device Identifier: 05415067031587
• UDI-Public: (01)05415067031587(17)260730
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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: 07/30/2026
• Device Model Number: NVTR-25
• Device Catalogue Number: NVTR-25
• Device Lot Number: 9200437
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 60 KG