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	Arrhythmia (1721); Atrial Fibrillation (1729); Fatigue (1849); Fever (1858); Perforation (2001); Shock (2072); Respiratory Tract Infection (2420)
Date of Event	02/12/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2025, a 23mm navitor valve was successfully implanted at a depth of 3mm using a small flexnav delivery system (ds) without issue.There was no calcification extending beneath the aortic annular plane in the interventricular septum.On (b)(6) 2025, the patient presented with atrial fibrillation (af), which was reverted.On (b)(6) 2025, the patient¿s heart rate was able to be controlled.On (b)(6) 2025, the patient was noted to have a fever, lethargy, and another occurrence of af.Antibiotics and amiodarone were administered to treat the issue.On (b)(6) 2025, the patient was able to be stabilized.On (b)(6) 2025, an ecg was repeated, showing a wider qrs.It was decided to continue treating the patient with antibiotics, and a pacemaker was also implanted.After this, the patient ended up going into shock and an x-ray indicated possible ventricular perforation.The patient then became unstable, and a pericardial puncture and drain was attempted.The patient¿s hemodynamics didn't improve and they passed away (b)(6) 2025.The physician believes that it was likely due to a multi-resistant pseudomonas infection.
Additional Manufacturer Narrative
The device was not returned for analysis.An event of fatigue, respiratory tract infection, shock, atrial fibrillation and patient death 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 all available information, causes for the reported fatigue, respiratory tract infection, shock, atrial fibrillation and patient death could not be conclusively determined.It is possible that they are related to the implant procedure.However, this cannot be confirmed.The reported death appears to be related to the multi-resistant pseudomonas infection.The reported unexpected medical intervention and surgical intervention were the result of case-specific circumstances, as pericardiocentesis was performed and permanent pacemaker implanted.The event and imaging was reviewed by an abbott senior director of medical affairs.The reviewer stated, the cause of death cannot be determined based on the information provided.However, we suspect its related to the right ventricular (rv) puncture from the temporary pacemaker placement.No device malfunction is suspected.
Event or Problem Description
It was reported that on (b)(6) 2025, a 23mm navitor valve was successfully implanted at a depth of 3mm using a small flexnav delivery system (ds) without issue.There was no calcification extending beneath the aortic annular plane in the interventricular septum.On (b)(6) 2025, the patient presented with atrial fibrillation (af), which was reverted.On (b)(6) 2025, the patient¿s heart rate was able to be controlled.On (b)(6) 2025, the patient was noted to have a fever, lethargy, and another occurrence of af.Antibiotics and amiodarone were administered to treat the issue.On (b)(6) 2025, the patient was able to be stabilized.On (b)(6) 2025, an ecg was repeated, showing a wider qrs.It was decided to continue treating the patient with antibiotics, and a pacemaker was also implanted.After this, the patient ended up going into shock and an x-ray indicated possible ventricular perforation.The patient then became unstable, and a pericardial puncture and drain was attempted.The patient¿s hemodynamics didn't improve and they passed away (b)(6) 2025.The physician believes that it was likely due to a multi-resistant pseudomonas infection.

• 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: 21588182
• Report Number: 2135147-2025-01238
• Device Sequence Number: 18359812
• Product Code: NPT
• UDI-Device Identifier: 05415067031570
• UDI-Public: (01)05415067031570(17)260905
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 05/05/2025

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: 09/05/2026
• Device Model Number: NVTR-23
• Device Catalogue Number: NVTR-23
• Device Lot Number: 10001088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2023
• 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; Death
• Patient Age: 87 YR
• Patient Sex: Female