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

Model Number	NVTR-23
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	10/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical information: crd_1003 - vantage, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 23mm navitor valve was chosen for implant using a small flexnav delivery system.The activated clotting levels were 273s and heparin given.A pre-implant balloon valvuloplasty done with a 18mm non-abbott balloon.The valve re-sheathed 2 times due to implant depth was high and non-uniform expansion.The final implant depth at non-coronary cusp (ncc) was 4.43mm and at left coronary cusp (lcc) was 4.45mm.On (b)(6) 2025, a computerized tomography (ct) scan showed circumferential thrombosis within the prosethic valve in the left ventricular outflow tract with a thickness of approximately 2.9mm.On (b)(6) 2024, a transthoracic echocardiogram (tte) showed the gradients were increased.On (b)(6) 2025, showed decreased gradients.
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.
Additional Manufacturer Narrative
An event involving difficulty in folding, unfolding, or collapsing the device, along with a patient¿device interaction issue (thrombus), was reported.A returned device inspection could not be performed because the device remains implanted and was not available for analysis.The device history record was reviewed and confirmed that all manufacturing and inspection steps were completed, and the product met all applicable specifications.The cause of the reported patient¿device interaction related to thrombus and leaflet thickening could not be determined.Valve under-expansion due to procedural factors is a possible contributor; however, this cannot be confirmed.The reported hospitalization and unexpected medical intervention were related to case-specific circumstances, as the patient returned to the hospital and was treated with medication.There is no indication of a product quality issue related to manufacturing, design, or labeling.
Event or Problem Description
Clinical information: crd_1003 - vantage, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 23mm navitor valve was chosen for implant using a small flexnav delivery system.The activated clotting levels were 273s and heparin given.A pre-implant balloon valvuloplasty done with a 18mm non-abbott balloon.The valve re-sheathed 2 times due to implant depth was high and non-uniform expansion.The final implant depth at non-coronary cusp (ncc) was 4.43mm and at left coronary cusp (lcc) was 4.45mm.On (b)(6) 2025, a computerized tomography (ct) scan showed circumferential thrombosis within the prosethic valve in the left ventricular outflow tract with a thickness of approximately 2.9mm.On (b)(6) 2024, a transthoracic echocardiogram (tte) showed the gradients were increased.On (b)(6) 2025, showed decreased gradients.The patient was reported 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: 23924309
• Report Number: 2135147-2025-07819
• Device Sequence Number: 15713681
• Product Code: NPT
• UDI-Device Identifier: 05415067031570
• UDI-Public: (01)05415067031570(17)251129
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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: 11/29/2025
• Device Model Number: NVTR-23
• Device Catalogue Number: NVTR-23
• Device Lot Number: 8816693
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 53 KG