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

Model Number	NVTR-27
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
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 on (b)(6) 2025 a 27mm navitor transcatheter aortic valve was selected for implant using a large flexnav delivery system.The patient's annulus was measured at a perimeter of 75mm, and the left ventricular outflow tract (lvot) was 67mm.Pre-dilation was performed with a 22mm non-abbott balloon.During the procedure at 80% deployment, the valve depth was 4mm from the non-coronary cusp (ncc) and 1mm from the left coronary cusp (lcc).At full deployment the implant depth on the lcc was 3mm and the ncc was 0mm with a mild-severe perivalvular leak.A second 27mm navitor transcatheter aortic valve was implanted at an implant depth of 4-5mm on the ncc and 5mm on the lcc.The patient remained hemodynamically stable throughout the procedure.The patient did not present with any clinical signs or symptoms.The patient status was stable.
Additional Manufacturer Narrative
An event of the perivalvular leak and device malposition was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The possible causes for perivalvular leak are sizing of the valve, implant depth, calcium distribution, deployment difficulties and inadequate radial forces.Information received appeared to show the valve implant depth was less than intended may have resulted in causing perivalvular leak.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 information received, the cause of the reported perivalvular leak could be due to implant depth but cannot be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported on (b)(6) 2025 a 27mm navitor transcatheter aortic valve was selected for implant using a large flexnav delivery system.The patient's annulus was measured at a perimeter of 75mm, and the left ventricular outflow tract (lvot) was 67mm.Pre-dilation was performed with a 22mm non-abbott balloon.During the procedure at 80% deployment, the valve depth was 4mm from the non-coronary cusp (ncc) and 1mm from the left coronary cusp (lcc).At full deployment the implant depth on the lcc was 3mm and the ncc was 0mm with a mild-severe perivalvular leak.A second 27mm navitor transcatheter aortic valve was implanted at an implant depth of 4-5mm on the ncc and 5mm on the lcc.The patient remained hemodynamically stable throughout the procedure.The patient did not present with any clinical signs or symptoms.The patient status was stable.

• 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: 23694727
• Report Number: 2135147-2025-07062
• Device Sequence Number: 9082688
• Product Code: NPT
• UDI-Device Identifier: 05415067031594
• UDI-Public: (01)05415067031594(17)260104
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/04/2026
• Device Model Number: NVTR-27
• Device Catalogue Number: NVTR-27
• Device Lot Number: 8853848
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 12/13/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2023
• 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: 75 YR
• Patient Sex: Male