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

Model Number	NVTR-25
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Perforation (2001); Cardiac Tamponade (2226)
Date of Event	02/03/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that on 03 feb.2025, a 25mm navitor valve (sn: (b)(6)) was selected for implant using a small flexnav delivery system (ds) (lot: 10441074).During the procedure, when the ds was inserted into the right femoral artery, the radiopaque tip and inner shaft had become bent.The system was removed from the patient and the navitor valve was loaded into a new small flexnav ds (lot: 10458760).The new system was then inserted and while the navitor was at 70% deployment, the patient experienced severe bradycardia followed by cardiac arrest.The valve was implanted and resuscitation maneuvers were performed returning the patient to their normal pacing.The sonographer then diagnosed a right ventricular perforation and bleeding on the right side of the heart leading to cardiac tamponade.The patient experienced another cardiac arrest and passed away.The physician alleges the caused to be due to the temporary pacemaker.
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.
Additional Manufacturer Narrative
The device was not returned for analysis.An event of death, bradycardia, perforation, and cardiac tamponade was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The event and imaging was reviewed by an abbott senior director of medical affairs.Based on all available information, causes for the reported bradycardia, perforation, and cardiac tamponade could not be conclusively determined.The reported death appears to be related to the cardiac tamponade.The reported unexpected medical intervention was the result of case-specific circumstances.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2025, a 25mm navitor valve (sn: (b)(6)) was selected for implant using a small flexnav delivery system (ds) (lot: 10441074).At the beginning of the procedure it was noted that a temporary pacemaker was placed on the right side of the heart.The pacemaker was turned off after pre-dilatation was performed.During the procedure, when the ds was inserted into the right femoral artery, the radiopaque tip and inner shaft had become bent.The system was removed from the patient and the navitor valve was loaded into a new small flexnav ds (lot: 10458760).The new system was then inserted and while the navitor was at 70% deployment, the patient experienced severe bradycardia followed by cardiac arrest.The valve was implanted and resuscitation maneuvers were performed returning the patient to their normal pacing.The sonographer then diagnosed a right ventricular perforation and bleeding on the right side of the heart leading to cardiac tamponade.The patient experienced another cardiac arrest and passed away in the intensive care unit (icu).The physician alleges the caused to be due to the temporary pacemaker.
Event or Problem Description
It was reported that on (b)(6) 2025, a 25mm navitor valve (sn: (b)(6)) was selected for implant using a small flexnav delivery system (ds) (lot: 10441074).At the beginning of the procedure it was noted that a temporary pacemaker was placed on the right side of the heart.The pacemaker was turned off after pre dilatation was performed.During the procedure, when the ds was inserted into the right femoral artery, the radiopaque tip and inner shaft had become bent.The system was removed from the patient and the navitor valve was loaded into a new small flexnav ds (lot: 10458760).The new system was then inserted and while the navitor was at 70% deployment, the patient experienced severe bradycardia followed by cardiac arrest.The valve was implanted and resuscitation maneuvers were performed returning the patient to their normal pacing.The sonographer then diagnosed a right ventricular perforation and bleeding on the right side of the heart leading to cardiac tamponade.The patient experienced another cardiac arrest and passed away in the intensive care unit (icu).The physician alleges the caused to be due to the temporary pacemaker.
Additional Manufacturer Narrative
Correction: a3.

• 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: 21479560
• Report Number: 2135147-2025-00983
• Device Sequence Number: 18251817
• Product Code: NPT
• UDI-Device Identifier: 05415067031587
• UDI-Public: (01)05415067031587(17)260809
• 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,Followup
• Report Date (Section B): 09/19/2025

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: 08/09/2026
• Device Model Number: NVTR-25
• Device Catalogue Number: NVTR-25
• Device Lot Number: 9214234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 03/11/2025; 08/28/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 03/19/2025; 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2023
• 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 Sex: Female