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

Model Number	NVTR-29
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Perivalvular Leak (1457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 29mm navitor valve was chosen for a transcatheter aortic valve replacement (tavr) procedure using a large flexnav delivery system.The annular dimensions of the native valve were diameter min:23.8 mm, diameter max:30.7mm, diameter avg: 27.3mm, area: 556.1mm^2, perimeter: 85.0mm| left ventricular outflow tract (lvot): diameter min:23.2 mm, diameter max:30.5mm, diameter avg: 26.9mm, area: 545.6mm^2, perimeter: 84.3mm.During procedure, a pre-dilation was performed with a 23mm x 40 mm non-abbott balloon.After the first deployment, a non-uniform expansion (nue) was present and it got re-captured and released, nue disappear.The final implant depth was 4mm on the non-coronary cusp/ncc).After the implant, a moderate perivalvular leak was noted.A post dilatation was performed with a 25mm x 40 mm non-abbott balloon but (pvl) remained.The heart team decided to deliver a non-abbott valve.The patient was reported stable.
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of incomplete stent opening and perivalvular leak (pvl) was reported.A returned device assessment could not be performed as the device remains implanted and 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 pvl and incomplete stent opening could not be conclusively determined.The reported surgical and unexpected medical intervention were results of case-specific circumstances as post-implant balloon valvuloplasty was performed to address the pvl and subsequently another valve was implanted (valve-in-valve).There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 22814782
• Report Number: 2135147-2025-04537
• Device Sequence Number: 15642572
• Product Code: NPT
• UDI-Device Identifier: 05415067031600
• UDI-Public: (01)05415067031600(17)260624
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 10/24/2025

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: 06/24/2026
• Device Model Number: NVTR-29
• Device Catalogue Number: NVTR-29
• Device Lot Number: 9141953
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2023
• 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: Female