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 Codes	Angina (1710); Hematoma (1884)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Na.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
It was reported that on (b)(6) 2025, a 27mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).The annulus perimeter and minimum diameter were measured to be 78.5mm and 21.9mm respectively.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed using a 23mm, non-abbott balloon.During the procedure, the initial position was noted to be high at the non-coronary cusp (ncc).At the second attempt, the valve was able to be implanted successfully at a depth of 3-4mm on the non-coronary cusp (ncc).A mild pvl was noted so post-implant balloon aortic valvuloplasty (post-bav) was performed using the same 23mm, non-abbott balloon as an intervention.After post-bav, the patient developed chest pain.Angiogram revealed coronary arteries were not obstructed.The patient's chest pain subsequently resolved.The patient remained hemodynamically stable throughout the procedure, and there was no clinically significant delay reported.However, follow-up imaging later identified the development of an aortic hematoma for which the patient was admitted in hospital for monitoring.The patient's status was stable and recovering expected to get discharged on (b)(6) 2025.
Additional Manufacturer Narrative
An event of 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 all available information, the reported pvl could not be conclusively determined.It is possible patient conditions.However, this cannot be confirmed.The reported hospitalization may represent cascade effect resulting from the reported pvl.The reported unexpected medical intervention is the result of case-specific circumstances, as post-implant valvuloplasty was performed.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2025, a 27mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).The annulus perimeter and minimum diameter were measured to be 78.5mm and 21.9mm respectively.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed using a 23mm, non-abbott balloon.During the procedure, the initial position was noted to be high at the non-coronary cusp (ncc).At the second attempt, the valve was able to be implanted successfully at a depth of 3-4mm on the non-coronary cusp (ncc).A mild pvl was noted so post-implant balloon aortic valvuloplasty (post-bav) was performed using the same 23mm, non-abbott balloon as an intervention.After post-bav, the patient developed chest pain.Angiogram revealed coronary arteries were not obstructed.The patient's chest pain subsequently resolved.The patient remained hemodynamically stable throughout the procedure, and there was no clinically significant delay reported.However, follow-up imaging later identified the development of an aortic hematoma for which the patient was admitted in hospital for monitoring.The patient's status was stable and recovering expected to get discharged on (b)(6) 2025.

• 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: 23662997
• Report Number: 2135147-2025-07028
• Device Sequence Number: 16060006
• Product Code: NPT
• UDI-Device Identifier: 05415067031594
• UDI-Public: (01)05415067031594(17)260816
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/05/2026

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: 08/16/2026
• Device Model Number: NVTR-27
• Device Catalogue Number: NVTR-27
• Device Lot Number: 9230931
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2023
• 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: 75 YR
• Patient Sex: Female