ABBOTT MEDICAL NAVITOR TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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Catalog Number NVTR-29 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/21/2024 |
Event Type
malfunction
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Event Description
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It was reported that a 29mm navitor transcatheter aortic valve was selected for implant on (b)(6) 2024.The patient had a pre-existing condition of severe aortic stenosis.During implant it was observed that while attempting to position the device, the device was maneuvered to the descending aorta to close the gap between the valve capsule and nosecone.It was noted that the non-abbott guidewire jumped from the ventricular position.The device was removed from the patient.During device preparation with the same valve and new large flexnav delivery system, it was noted that one of the leaflets was more wrinkled and had what appeared to be a "bite zone".The 29mm valve was replaced with a new 29mm navitor transcatheter aortic valve.The patient did not present with any clinical signs or symptoms.The patient status was stable.
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Manufacturer Narrative
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An event of material deformation (wrinkle) on the leaflet was reported.The device was returned for analysis, but no anomalies were found with the stents or the leaflets.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
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Event Description
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It was reported that a 29mm navitor transcatheter aortic valve was selected for implant on (b)(6) 2024.The patient had a pre-existing condition of severe aortic stenosis.During implant it was observed that while attempting to position the device, the device was maneuvered to the descending aorta to close the gap between the valve capsule and nosecone.It was noted that the non-abbott guidewire jumped from the ventricular position.The device was removed from the patient.During device preparation with the same valve and new large flexnav delivery system, it was noted that one of the leaflets was more wrinkled and had what appeared to be a "bite zone".The 29mm valve was replaced with a new 29mm navitor transcatheter aortic valve.The patient did not present with any clinical signs or symptoms.The patient status was stable.
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Search Alerts/Recalls
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