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

Model Number	NVTR-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Heart Block (4444)
Date of Event	07/25/2025
Type of Reportable Event	Serious Injury
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
Clinical information: crd_1003 - vantage, patient site id: (b)(6).It was reported that on (b)(6) 2025, a 23mm navitor valve was successfully implanted in a patient.A pre-implant balloon aortic valvuloplasty was not performed.The length of the membranous septum was 4.0mm.While in cusp overlap view and prior to deployment, the inflow edge of the constrained valve frame was aligned at the base of the non-coronary cusp.The valve was re-sheathed once during procedure due to being deployed too low.The final non-coronary cusp implant depth was 5.59mm.Post-procedure, a physical exam revealed that the patient had worsening hypertension of 210/70.The decision was made to start the patient an perganit ev and prescribe a regimen of amlodipine, spironolactone, and cardura.On (b)(6) 2025, it was noted via electrocardiogram showed a sinus rhythm and left anterior fascicular block.No intervention was performed.The patient was in stable condition at the time of report.No additional information was provided.
Event or Problem Description
Clinical information: (b)(4) - vantage, patient site id: (b)(6).It was reported that on (b)(6) 2025, a 23mm navitor valve was successfully implanted in a patient.A pre-implant balloon aortic valvuloplasty was not performed.The length of the membranous septum was 4.0mm.While in cusp overlap view and prior to deployment, the inflow edge of the constrained valve frame was aligned at the base of the non-coronary cusp.The valve was re-sheathed once during procedure due to being deployed too low.The final non-coronary cusp implant depth was 5.59mm.Post-procedure, a physical exam revealed that the patient had worsening hypertension of 210/70.The decision was made to start the patient an perganit ev and prescribe a regimen of amlodipine, spironolactone, and cardura.On (b)(6) 2025, it was noted via electrocardiogram showed a sinus rhythm and left anterior fascicular block.No intervention was performed.The patient was in stable condition at the time of report.No additional information was provided.
Additional Manufacturer Narrative
An event of hypertension and left anterior fascicular block 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 hypertension and left anterior fascicular block could not be conclusively determined.The reported unexpected medical intervention was a result of case-specific circumstances as medications were administered to address the hypertension.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: health effect-clinical code: component code: 4755 part/component/sub-assembly term not applicable type of investigation: 4118 types of investigation not yet determined investigation findings: 3233 results pending completion of investigation.Investigation conclusions: 11 conclusions not yet available.

• 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: 22892100
• Report Number: 2135147-2025-04777
• Device Sequence Number: 15692781
• Product Code: NPT
• UDI-Device Identifier: 05415067031570
• UDI-Public: (01)05415067031570(17)260515
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Study,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: 05/15/2026
• Device Model Number: NVTR-23
• Device Catalogue Number: NVTR-23
• Device Lot Number: 9089597
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2023
• 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: 83 YR
• Patient Sex: Male
• Patient Weight: 65 KG