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

Model Number	NVTR-27
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	11/28/2024
Type of Reportable Event	Death
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
This complaint consists of tht registry data from japan.The data did not contain lot number, unique device identifier (udi).The information was obtained through the registry, no further details have become available for this event.It was reported through the tht registry from japan that on (b)(6) 2024, a 27mm navitor valve was implanted.On (b)(6) 2024, the patient expired.The cause of death was cardiovascular, originating from a cardiovascular event.The death was due to heart failure, following repeated femoral neck fractures.
Additional Manufacturer Narrative
An event of patient death was reported.It was also reported that the cause of death was due to heart failure, following repeated femoral neck fractures.A more comprehensive assessment could not be performed as limited information was available, and the device 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 death is attributed to heart failure and is not considered related to a navitor device malfunction or the tavi procedure.No new hazards or harms were identified that would alter the current benefit¿risk profile.Additionally, there was no evidence of a product issue or concerns regarding the device¿s labeling or design.Therefore, no remedial action is required at this time.

• 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: 24747136
• Report Number: 2135147-2026-02062
• Device Sequence Number: 15760657
• Product Code: NPT
• UDI-Device Identifier: 05415067031594
• UDI-Public: (01)05415067031594(17)260514
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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: 05/14/2026
• Device Model Number: NVTR-27
• Device Catalogue Number: NVTR-27
• Device Lot Number: 9093149
• 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: 03/06/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2023
• 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: Death; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female