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

Catalog Number	NVTR-25
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Obstruction/Occlusion (2422)
Date of Event	12/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The date of death was estimated to be (b)(6) 2024.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 04 dec.2024, 25mm navitor valve was selected for implant.The native aortic annulus had moderately calcified leaflets.The native aortic annulus perimeter was 70mm, and the diameter was 22mm.During the procedure, when the device was at 80% deployment, it was within -4mm of the ring plane.The patient became hypotensive, and the final deployment of the valve was a bit fast.The device was fully released, and all 3 tabs were confirmed to have successfully released.However, despite checking that the 3 tabs were detached, the nose cone came out against the wall of the aorta.A few seconds after the device was fully released, it was noted that the device migrated upwards to the ascending aorta.The valve was blocking the left coronary artery for about 10-15 minutes.This caused the patient to go into cardiac arrest requiring cardiac massage and electric shock.The physicians tried to snare the device and then use a balloon to raise the navitor above the coronary arteries to avoid occlusion and allow revascularization of the left coronary artery.Then the 23mm non-abbott device was implanted via valve-in-valve procedure.The patient was stable at the end of the procedure.The cause of the migration was believed to be due to poor valve anchoring in the final deployment.It was noted that 3-4 days later that the patient has passed away.
Event or Problem Description
It was reported that on (b)(6) 2024, 25mm navitor valve was selected for implant.The native aortic annulus had moderately calcified leaflets.The native aortic annulus perimeter was 70mm, and the diameter was 22mm.During the procedure, when the device was at 80% deployment, it was within -4mm of the ring plane.The patient became hypotensive, and the final deployment of the valve was a bit fast.The device was fully released, and all 3 tabs were confirmed to have successfully released.However, despite checking that the 3 tabs were detached, the nose cone came out against the wall of the aorta.A few seconds after the device was fully released, it was noted that the device migrated upwards to the ascending aorta.The valve was blocking the left coronary artery for about 10-15 minutes.This caused the patient to go into cardiac arrest requiring cardiac massage and electric shock.The physicians tried to snare the device and then use a balloon to raise the navitor above the coronary arteries to avoid occlusion and allow revascularization of the left coronary artery.Then the 23mm non-abbott device was implanted via valve-in-valve procedure.The patient was stable at the end of the procedure.The cause of the migration was believed to be due to poor valve anchoring in the final deployment.It was noted that 3-4 days later that the patient has passed away.
Additional Manufacturer Narrative
B2 - date of death is estimated.The device was not returned for analysis.An event of migration, occlusion, hypotension, cardiac arrest, and 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.The event and provided image were reviewed by an abbott director of medical affairs.Based on all available information, a cause for the reported migration could not be conclusively determined.The reported occlusion, hypotension, and cardiac arrest appear to be cascading events of the migration.The reported death appears to be related to the procedure, per the medical review.The reported surgery and unexpected medical interventions (snare, cpr) are the results of case-specific circumstances.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.

• 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: 21028049
• Report Number: 2135147-2024-06636
• Device Sequence Number: 3969664
• Product Code: NPT
• UDI-Device Identifier: 05415067031587
• UDI-Public: (01)05415067031587(17)261211(10)10143902
• 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: 2024
• 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): 02/06/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: NVTR-25
• Device Lot Number: 10143902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2023
• 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: Required Intervention; Death
• Patient Sex: Unknown