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

Model Number	NVTR-23
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Perforation (2001); Pericardial Effusion (3271); Insufficient Information (4580)
Date of Event	03/04/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
N/a.It is unknown if the device is returning for analysis.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 23 mm navitor valve was implanted.On an unknown date, the patient was noted to have passed away due to aortic injury.
Event or Problem Description
Subsequent to the previously filed report, additional information was received: it was reported that on (b)(6) 2025, a 23mm navitor valve was implanted.The patient had mostly fibrotic aortic stenosis and obstructive cardiomyopathy.There was no difficulty noted during the procedure, no allergy known to metal, no angulated or horizontal aorta, no oversized prosthesis nor dilated aorta, and no pre- or post-dilation was required.Three weeks post procedure, the patient began complaining of continuous chest pain.A ct scan was performed and showed that the patient had suffered an aortic wall rupture due to the pad going through the aortic wall.Shortly after the ct scan, the patient went into sudden cardiac dissociated arrest and an immediate pericardiocentesis was performed, but there was poor drainage.The patient passed away due to the aortic injury.
Additional Manufacturer Narrative
The device was not returned for analysis.An event of implant-related tissue damage-aortic perforation was reported.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 information received, the cause of the reported implant-related tissue damage-aortic perforation was due to the pad going through the aortic wall.The cause of the reported death was due to the aortic injury.The reported hypotension was a cascading effect of aortic injury.The cause of the reported pericardial effusion could not be determined.The reported hospitalization and unexpected medical intervention were a result of case-specific circumstances.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.Codes removed: h6 health effect-clinical code: 4580 insufficient information.H6 medical device problem code: 2993 adverse event without identified device or use problem.Codes added: h6 health effect-clinical code: 3271 pericardial effusion, 1914 low blood pressure, 2001 perforation.H6 health effect - impact code: 4607 hospitalization, 4641 unexpected medical intervention.H6 medical device problem code: 2682 patient-device incompatability.

• 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: 21722530
• Report Number: 2135147-2025-01637
• Device Sequence Number: 9491656
• Product Code: NPT
• UDI-Device Identifier: 05415067031570
• UDI-Public: (01)05415067031570(17)261008
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/26/2025

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 Model Number: NVTR-23
• Device Catalogue Number: NVTR-23
• Device Lot Number: 10053354
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2023
• 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; Death; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female