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

Model Number	NVTR-23
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Off-Label Use (1494)
Health Effect - Clinical Codes	Anemia (1706); Bradycardia (1751); Heart Block (4444)
Date of Event	01/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
Clinical information: (b)(6): it was reported that on (b)(6) 2025, a 23mm navitor valve was successfully implanted in a patient.A pre-implant balloon aortic valvuloplasty was not performed due to the patient having a low mean aortic valve gradient.While in cusp overlap view and prior to deployment, the inflow edge of the constrained valve frame was aligned at the base of the non-coronary cusp.The valve was re-sheathed once due to being deployed too high.A post-implant balloon aortic valvuloplasty was performed using a 20mm non-abbott device due to valve under expansion.At 80% deployment, the implanter did switch to left anterior oblique (lao) view and confirmed with stent parallax removed that the implant depth was at an acceptable level below annulus in that view.The final non-coronary cusp implant depth was 2.47mm.There was calcium noted from the left coronary cusp to the left ventricular outflow tract.Post-procedure, it was noted via electrocardiogram that the patient developed an onset of bradycardia.The decision was made to place a temporary pacemaker.On (b)(6) 2025, it was noted via electrocardiogram that the patient developed a complete heart block.On (b)(6) 2025, the decision was made to implant a permanent pacemaker.On (b)(6) 2025, a reduction in the patient hemoglobin value was noted, but there was no bleeding.The decision was made to transfuse the patient with red blood cells and monitor by lower limb doppler.The cause of under expansion of the 23mm navitor valve is attributed to constriction of the 23mm navitor valve being implanted within a surgical aortic valve in a valve-in-valve procedure.The cause of the patient's bradycardia is attributed to the patient's pre-procedural rhythm and position of the valve.The patient was discharged at the time of report.
Additional Manufacturer Narrative
The device was not returned for analysis.An event of off-label use, valve underexpansion, device malposition, bradycardia, heart block, and anemia 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 reported valve underexpansion and device malposition appear to be related to the off-label use.The reported off-label use is related to the device being used for a valve-in-valve procedure.The reported bradycardia appears to be related to a combination of patient condition (abnormal pre-procedural rhythm) and procedural conditions (valve position).Causes for the heart block and anemia could not be conclusively determined.The reported unexpected medical interventions, hospitalization, and surgery were 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.In this case, the device was selected for a valve-in-valve procedure.This case is included in a pre-market clinical study investigating the safety and efficacy of the navitor valve in a valve-in-valve procedure.Therefore, a letter will not be sent to address the deviation from the ifu.

• Brand Name: NAVITOR TRANSCATHETER AORTIC VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21490927
• Report Number: 2135147-2025-01005
• Device Sequence Number: 3995439
• Product Code: NPT
• UDI-Device Identifier: 05415067031570
• UDI-Public: (01)05415067031570(17)250314
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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: 03/14/2025
• Device Model Number: NVTR-23
• Device Catalogue Number: NVTR-23
• Device Lot Number: 8674858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2022
• 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
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 67 KG