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

Catalog Number	NVTR-25
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Obstruction/Occlusion (2422)
Date of Event	01/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 (b)(6) 2025, a 25mm navitor valve was selected for implant.The patients calcification was considered adequate for anchoring of the valve.The anatomical measurements of the patient were: an aortic angle of 50 degrees, and annular dimensions of 72.1mm.During the procedure, a pre-dilation was performed with a 18mm non-abbott balloon.During implant, the patient was hemodynamically unstable during deployment, so the valve was implanted quickly at a depth of 2mm ncc and lcc.The valve was under-expanded as a result and ended up migrating toward the aorta.The migrated valve blocked coronary arteries and caused the patient to go into cardiac arrest.A valve-in-valve was then performed with good expansion with mild pvl, which was deemed acceptable.The physician snared one of the first valve tabs closer to lesser curvature.Ecmo was then administered to stabilize hemodynamics.The patient was transferred to the icu and is stable.
Additional Manufacturer Narrative
The device was not returned for analysis.An event of valve under-expansion, migration, cardiac arrest, occlusion 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, the cause of the reported cardiac arrest appears to be due to coronary occlusion.The reported coronary occlusion appears to be due to the device migration.The cause of the reported migration appears to be due to the valve under-expansion.The cause of the reported under-expansion could not be conclusively determined.The reported unexpected medical interventions and surgery are results 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 was selected for implant.The patients calcification was considered adequate for anchoring of the valve.The anatomical measurements of the patient were: an aortic angle of 50 degrees, and annular dimensions of 72.1mm.During the procedure, a pre-dilation was performed with a 18mm non-abbott balloon.During implant, the patient was hemodynamically unstable during deployment, so the valve was implanted quickly at a depth of 2mm ncc and lcc.The valve was under-expanded as a result and ended up migrating toward the aorta.The migrated valve blocked coronary arteries and caused the patient to go into cardiac arrest.A valve-in-valve was then performed with good expansion with mild pvl, which was deemed acceptable.The physician snared one of the first valve tabs closer to lesser curvature.Ecmo was then administered to stabilize hemodynamics.The patient was transferred to the icu and is stable.

• 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: 21242027
• Report Number: 2135147-2025-00418
• Device Sequence Number: 20983893
• Product Code: NPT
• UDI-Device Identifier: 05415067031587
• UDI-Public: (01)05415067031587(17)260530(10)9111516
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 02/21/2025

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 Expiration Date: 05/30/2026
• Device Catalogue Number: NVTR-25
• Device Lot Number: 9111516
• 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: 01/02/2025
• Supplement Date Received by Manufacturer: 02/15/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2023
• 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
• Patient Sex: Male